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Recall Observatory FDA recall evidence

Drug product

Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202

D-0684-2018

March 27, 2018

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 79612
Status
Terminated
Classification
Class II
Quantity
40,824 bottles
Official record key
drug-enforcement:D-0684-2018

Official wording

Reason: Superpotent Drug

Code information: Lot # F602241; Exp. 10/18 Lot # F602577; Exp. 11/18 Lot # F700036; Exp. 12/18

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent