FDA-Drug2014-11-12Class II

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10

Pharmaceutical Associates Inc
Hazard

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Sold states
Nationwide
Affected count
9,640 unit dose cups
Manufactured in
201 Delaware St, N/A, Greenville, SC, United States
Products
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0240-2015

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