Pharmaceutical Associates Recalls Cyproheptadine HCl Syrup Due to Impurity
Pharmaceutical Associates Inc. is recalling 9,640 unit dose cups of Cyproheptadine HCl Syrup because an unidentified impurity exceeded specifications during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk associated with an unidentified impurity, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmaceutical Associates Inc. is recalling 9,640 unit dose cups of Cyproheptadine HCl Syrup (NDC 0121-4788-10). The product is a prescription-only oral solution with a concentration of 4mg/10 mL. The specific lot affected is 3H43, with an expiration date of 02/15.
The recall was initiated due to a failed impurities/degradation specification. Specifically, the product produced an out-of-specification result for an unidentified impurity at the 12-month stability test point. The agency has classified this recall as Class II.
The affected product was distributed nationwide. Consumers and healthcare providers should discontinue use of the recalled product and contact their pharmacist or physician for guidance on replacement or alternative treatment.
The recalled product
- Product
- Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
- Manufacturer
- Pharmaceutical Associates Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 9,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 3H43
- Exp. 02/15
Distribution
Distributed nationwide across the United States.
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