Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
Reported: November 12, 2014 Initiated: October 16, 2014 #D-0240-2015
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.
Details
- Recalling Firm
- Pharmaceutical Associates Inc
- Units Affected
- 9,640 unit dose cups
- Distribution
- Nationwide
- Location
- Greenville, SC
Frequently Asked Questions
What product was recalled? ▼
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10. Recalled by Pharmaceutical Associates Inc. Units affected: 9,640 unit dose cups.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 12, 2014. Severity: Moderate. Recall number: D-0240-2015.
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