Recalls / Class II
Class IID-1043-2016
Product
1% Clotrimazol cream, 30 mg tube, UPC 501318644335
- Affected lot / code info
- Lot # GRU1390; Exp. 08/17
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Profarma Distributors LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4751 Poth Rd, N/A, Columbus, Ohio 43213-1331
Distribution
- Quantity
- 79 boxes (79 tubes)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-11
- FDA classified
- 2016-06-17
- Posted by FDA
- 2016-06-29
- Terminated
- 2017-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1043-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.