Recalls / Class III
Class IIID-0599-2018
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
- Brand name
- Hydrocodone Bitartrate And Homatropine Methylbromide
- Generic name
- Hydrocodone Bitartrate And Homatropine Methylbromide
- Active ingredients
- Homatropine Methylbromide, Hydrocodone Bitartrate
- Route
- Oral
- NDC
- 43386-118
- FDA application
- ANDA091528
- Affected lot / code info
- M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Novel Laboratories, Inc.
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 134,364 bottles (4,030,920 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-03-05
- FDA classified
- 2018-03-14
- Posted by FDA
- 2018-03-21
- Terminated
- 2020-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0599-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.