July 2020 FDA Recall Cefdinir by Lupin Pharmaceuticals Inc.
D-1406-2020 - Superpotent Drug
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on July 2, 2020 for the product Cefdinir. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1406-2020
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
07-02-2020
07-29-2020
35,928 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
06-30-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Batch or Lot Expiration Information
Lot# F802189, Exp 10/2020, F900240, Exp 1/2021
