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Novel Laboratories

3 recalls •

• Categories: Prescription Drugs

Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038

Class I - Dangerous

Failed Impurities/Degradation Specifications

Mar 5, 2018 Prescription Drugs Nationwide View Details →

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60

Class I - Dangerous

Chemical Contamination

Feb 22, 2017 Prescription Drugs Nationwide View Details →

Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.

Class I - Dangerous

Failed Impurity/Degradation Specification; 12-month stability time point

Jun 20, 2014 Prescription Drugs Nationwide View Details →