FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
by Lupin Pharmaceuticals Inc.
- Reason
- Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
by B & B Pharmaceuticals, Inc.
- Reason
- cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144
by Filltech USA, LLC
- Reason
- Microbial contamination of non-sterile products: positive test for yeast and bacteria.
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
by Filltech USA, LLC
- Reason
- Microbial contamination of non-sterile products: positive test for yeast and bacteria.
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
by Golden State Medical Supply Inc.
- Reason
- CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mountain Rose Inc. dba Mountain Rose Herbs
- Product
- Kudzu Root (Pueraria montana var. lobata), This product was…
- Reason
- Salmonella
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01
by Avet Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01
by Avet Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
- Published
- April 15, 2020
- 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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