Cyproheptadine HCl Syrup recall: Impurity Out of Spec
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC…
Why was Cyproheptadine HCl Syrup recalled?
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 3H43, Exp. 02/15
- Product
- Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC…
- Recalling firm
- Pharmaceutical Associates Inc
- Quantity
- 9,640 unit dose cups
- Distribution
- Nationwide
- Recall date
- November 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)