Recalls / Class II
Class IID-0684-2018
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
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir
- Route
- Oral
- NDCs
- 68180-722, 68180-723
- FDA application
- ANDA065259
- Affected lot / code info
- Lot # F602241; Exp. 10/18 Lot # F602577; Exp. 11/18 Lot # F700036; Exp. 12/18
Why it was recalled
Superpotent Drug
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 40,824 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-03-27
- FDA classified
- 2018-04-17
- Posted by FDA
- 2018-04-25
- Terminated
- 2019-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0684-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.