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Recall Observatory FDA recall evidence

Drug product

Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10

D-1530-2020

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-1530-2020

Official wording

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

Code information: Lot #:19207; Exp. Date: 9/21; 19251, Exp. Date: 9/20; 19284, Exp. Date:10/20; 19316, Exp. Date: 12/20

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations