D-634-2013 Class II Terminated
FDA drug recall D-634-2013 was initiated by Clinical Specialties Compounding Pharmacy on March 20, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. The recall status is terminated (terminated February 22, 2017). Affected quantity: 10ml.
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2013
- Initiation Date
- March 20, 2013
- Termination Date
- February 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10ml
Product Description
Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Distribution Pattern
FL, GA and SC.
Code Information
Lot number CABDBDAC:98, Exp date: 8/12/2013