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Recall Observatory FDA recall evidence

Drug product

Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01

D-0768-2022

March 23, 2022

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 89924
Status
Terminated
Classification
Class II
Quantity
1568 bottles
Official record key
drug-enforcement:D-0768-2022

Official wording

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

Code information: Lot #: A0721O, A1421Y, A2121G, A2821D, B0421H, B0421I, B0521U, B1121G, B1921C, C0421B, C1821N, L0120F, L2320O, L3020T, Exp.: 4/30/2022; B2521A, C1121S, C2521U, D0121S, D0921B, D1421B, D2921C, E0721A, Exp.: 10/31/2022; D2221A, Exp.: 12/31/2022

Distribution pattern: IL

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations