Recalls / Class II
Class IID-632-2013
Product
Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Affected lot / code info
- Lot number CABCAFBA:73, Exp date: 9/30/2013
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recalling firm
- Firm
- Clinical Specialties Compounding Pharmacy
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 318 Baston Rd, N/A, Augusta, Georgia 30907
Distribution
- Quantity
- 300ml
- Distribution pattern
- FL, GA and SC.
Timeline
- Recall initiated
- 2013-03-20
- FDA classified
- 2013-07-03
- Posted by FDA
- 2013-07-10
- Terminated
- 2017-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-632-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.