Recalls / Class II
Class IID-0240-2015
Product
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
- Affected lot / code info
- Lot 3H43, Exp. 02/15
Why it was recalled
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Recalling firm
- Firm
- Pharmaceutical Associates Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Delaware St, N/A, Greenville, South Carolina 29605-5823
Distribution
- Quantity
- 9,640 unit dose cups
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-16
- FDA classified
- 2014-11-06
- Posted by FDA
- 2014-11-12
- Terminated
- 2017-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0240-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.