Drug Recall
Terminated
Historical recordClass III
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24
by Sun Pharmaceutical Industries, Inc.
- Reason
- Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
- Recall initiated
- December 26, 2018
- Reported by FDA
- January 30, 2019
- Distribution
- OH
View recall →
Drug Recall
Terminated
Historical recordClass II
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
by LUPIN SOMERSET
- Reason
- Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
- Recall initiated
- January 15, 2019
- Reported by FDA
- January 30, 2019
- Distribution
- Nationwide in the USA and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass II
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
- Recall initiated
- January 15, 2019
- Reported by FDA
- January 30, 2019
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass I
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
by Happy Together, Inc.
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
- Recall initiated
- January 8, 2019
- Reported by FDA
- January 30, 2019
- Distribution
- Product was sold over the internet
View recall →
Drug Recall
Terminated
Historical recordClass II
Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
by Bound Tree Medical, LLC
- Reason
- Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
- Recall initiated
- November 2, 2018
- Reported by FDA
- January 30, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
by Bound Tree Medical, LLC
- Reason
- Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
- Recall initiated
- November 2, 2018
- Reported by FDA
- January 30, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
by Bound Tree Medical, LLC
- Reason
- Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
- Recall initiated
- November 2, 2018
- Reported by FDA
- January 30, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
by Bound Tree Medical, LLC
- Reason
- Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
- Recall initiated
- November 2, 2018
- Reported by FDA
- January 30, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
by Teva Pharmaceuticals USA
- Reason
- Failed dissolution specifications
- Recall initiated
- December 19, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- U.S.A. nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviation; manufacturing batch record could not be located
- Recall initiated
- January 7, 2019
- Reported by FDA
- January 23, 2019
- Distribution
- Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
View recall →
Drug Recall
Terminated
Historical recordClass III
Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-amin Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016. Model 8600-01101
by Bound Tree Medical, LLC
- Reason
- Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
- Recall initiated
- November 1, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01
by Syntho Pharmaceuticals, Inc.
- Reason
- CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
- Recall initiated
- April 17, 2017
- Reported by FDA
- January 23, 2019
- Distribution
- Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
View recall →
Drug Recall
Terminated
Historical recordClass II
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
by Syntho Pharmaceuticals, Inc.
- Reason
- CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
- Recall initiated
- April 17, 2017
- Reported by FDA
- January 23, 2019
- Distribution
- Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
View recall →
Drug Recall
Terminated
Historical recordClass II
curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Producs, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016
by Bound Tree Medical, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance.
- Recall initiated
- November 1, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug Recall
Ongoing
Historical recordClass II
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Recall initiated
- December 31, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Recall initiated
- December 31, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Recall initiated
- December 31, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Recall initiated
- December 31, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Recall initiated
- December 31, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Recall initiated
- December 31, 2018
- Reported by FDA
- January 23, 2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
