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Recall Observatory FDA recall evidence

Drug product

Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01

D-0009-2021

September 16, 2020

Class II

Product summary

Firm
Calvin Scott & Company, Inc.
Event
Event 86442
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0009-2021

Official wording

Reason: cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.

Code information: Lot #: CS19311, CS19337, Exp 12/20; CS20018B, CS20019, CS20037, CS20075, CS20076, CS20112, CS20169, Exp 8/21; CS20168, Exp 12/21; CS20199, Exp 5/22; CS20243, Exp 7/22

Distribution pattern: Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.