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Recall Observatory FDA recall evidence

Drug product

Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0203-70

D-1526-2020

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-1526-2020

Official wording

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

Code information: Lot #:19197; Exp. Date: 8/20, 9/20, 10/20; 19341, Exp. Date: 1/21

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations