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Recall Observatory FDA recall evidence

Drug product

Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

D-0012-2021

August 24, 2020

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 86285
Status
Terminated
Classification
Class II
Quantity
103,940 bottles
Official record key
drug-enforcement:D-0012-2021

Official wording

Reason: CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Code information: Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.

Distribution pattern: Nationwide in the U.S. and Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations