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Recall Observatory FDA recall evidence

Drug product

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

D-1523-2020

July 27, 2020

Class II

Product summary

Firm
Calvin Scott & Company, Inc.
Event
Event 86123
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1523-2020

Official wording

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

Code information: Lot #: 19169; Exp. Date: 7/20, 08/20, 09/20; 19237, Exp. Date: 10/20, 11/20, 12/20; 19331, Exp. Date: 12/20; 20031, Exp. Date: 3/21

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations