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Recall Observatory FDA recall evidence

Drug product

Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.

D-1532-2020

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-1532-2020

Official wording

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

Code information: Lot #: a) 19271, Exp. Date 10/20 b) 19206, 19209B, Exp. Date 08/20; 19229, Exp. Date 10/20; 19255, Exp. Date 09/20; 19271, Exp. Date 08/20; 19301, Exp. Date 10/20; 19327, Exp. Date 11/20; 19336, Exp. 12/20; 20012, Exp. Date 1/21; 20045, Exp. Date 2/21.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations