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Recall Observatory FDA recall evidence

Drug product

Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.

D-1522-2020

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-1522-2020

Official wording

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

Code information: a) Lot #: 19236, Exp. Date 10/20 b) Lot #: 19170; 19236, Exp. Date: 09/20; 19303, Exp. Date: 11/20; 19347, Exp. Date: 12/20; 19353, Exp. Date: 01/21: 20032, 20047, Exp. Date: 2/21. c) Lot #: 19236, Exp. Date 10/20

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations