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 3433861

FDA recall notice · announced March 21, 2018 · Novel Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide
Lot/code information: M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
Quantity: 134,364 bottles (4,030,920 tablets)
Status: Terminated
Products in this recall event:
- 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 (D-0599-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.