Qualitest Pharmaceuticals recalls PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Ph…

Recall date

March 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D00432-2015

FDA classification

Class III

Brand / firm

Qualitest Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.