FDA Recall
Terminated
Historical recordClass III
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
by Claris Lifesciences Inc
- Reason
- Superpotent
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
by The Ampt Life, LLC
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
by Renaissance Lakewood, LLC
- Reason
- Superpotent
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: glass particulate found in vial
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
by EZWeightLossTX LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
by EZWeightLossTX LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
by Osmotica Pharmaceutical Corp
- Reason
- Subpotent Drug
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
by Osmotica Pharmaceutical Corp
- Reason
- Subpotent Drug
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512
by Sun Pharmaceutical Industries, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 20, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
- Published
- December 20, 2017
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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