Class III
Terminated
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
- Company
- Novel Laboratories, Inc.
- Recall Initiated
- March 5, 2018
- Posted
- March 21, 2018
- Recall Number
- D-0599-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 134,364 bottles (4,030,920 tablets)
- Firm Location
- Somerset, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide
Lot / Code Info
M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
More recalls by Novel Laboratories, Inc.
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