Drug & medication recalls Moderate risk

Phendimetrazine Brown/Clear Capsules recalled over manufacturing violations

Recall date
July 27, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Calvin Scott & Company, Inc. recalls Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquer…
Recall number
D-1523-2020
FDA classification
Class II
Brand / firm
Calvin Scott & Company, Inc.
Sold / distributed
Nationwide within the United States

Why it was recalled

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

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

What was recalled

Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11

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