Drug & medication recalls

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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