D-0240-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 12, 2014
- Initiation Date
- October 16, 2014
- Termination Date
- June 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,640 unit dose cups
Product Description
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
Reason for Recall
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Distribution Pattern
Nationwide
Code Information
Lot 3H43, Exp. 02/15