August 10, 2018
Hetero Labs is recalling 18,288 bottles of indomethacin manufactured for Camber Pharmaceuticals, Inc., following customer complaints of misshaped, melted, and clumped together capsules, according to the August 8, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 100-count bottles of indomethacin capsules, USP, 50 mg (NDC 31722-543-01), from lot E180315 (Exp. 12/19). The drugs were distributed across the United States.
Hetero Labs voluntarily initiated the recall July 18, 2018, which was designated Class II by the FDA July 27, 2018. Under Class II recalls, use of affected drugs can cause temporary or medically reversible adverse health consequences as well as a remote possibility of serious harm.
Indomethacin is a prescription nonsteroidal anti-inflammatory drug (NSAID) used to relieve inflammation, pain, and fever.
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