Recalls / Class III
Class IIID-0836-2018
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
- Brand name
- Hydrocodone Bitartrate And Acetaminophen
- Generic name
- Hydrocodone Bitartrate And Acetaminophen
- Active ingredients
- Acetaminophen, Hydrocodone Bitartrate
- Route
- Oral
- NDCs
- 43386-356, 43386-358, 43386-357
- FDA application
- ANDA206245
- Affected lot / code info
- Lot # S800257; Exp. 01/20
Why it was recalled
Labeling: Missing Label
Recalling firm
- Firm
- LUPIN SOMERSET
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 1,672 (1000-count) bottles
- Distribution pattern
- OH
Timeline
- Recall initiated
- 2018-05-24
- FDA classified
- 2018-05-31
- Posted by FDA
- 2018-06-06
- Terminated
- 2021-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0836-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.