FDA recall D-0240-2015

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-10-16

Report date

2014-11-12

Termination date

2017-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, SC, United States

Primary source

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