Novel Laboratories, Inc. recalls Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: No…
- Recall date
- March 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0599-2018
- FDA classification
- Class III
- Brand / firm
- Novel Laboratories, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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