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
Reported: June 6, 2018 Initiated: May 24, 2018 #D-0836-2018
Product Description
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
Reason for Recall
Labeling: Missing Label
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 1,672 (1000-count) bottles
- Distribution
- OH
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by LUPIN SOMERSET. Units affected: 1,672 (1000-count) bottles.
Why was this product recalled? ▼
Labeling: Missing Label
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 6, 2018. Severity: Low. Recall number: D-0836-2018.
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