Drug product
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
D-0240-2015
Product summary
- Event
- Event 69547
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,640 unit dose cups
- Official record key
drug-enforcement:D-0240-2015
Official wording
Reason: Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Code information: Lot 3H43, Exp. 02/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out-of-specification