Drug & medication recalls Moderate risk

Hetero Labs, Ltd. - Unit III recalls Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataw…

Recall date
July 18, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1019-2018
FDA classification
Class II
Brand / firm
Hetero Labs, Ltd. - Unit III
Sold / distributed
Nationwide in the USA

Why it was recalled

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.

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