D-1043-2016 Class II Terminated
FDA drug recall D-1043-2016 was initiated by Profarma Distributors LLC on May 11, 2016 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated January 24, 2017). Affected quantity: 79 boxes (79 tubes).
Recall Details
- Product Type
- Drugs
- Report Date
- June 29, 2016
- Initiation Date
- May 11, 2016
- Termination Date
- January 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 boxes (79 tubes)
Product Description
1% Clotrimazol cream, 30 mg tube, UPC 501318644335
Reason for Recall
CGMP Deviations
Distribution Pattern
Nationwide
Code Information
Lot # GRU1390; Exp. 08/17