FDAFDA · Food and drugs·Recall number D00432-2015
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.
Published April 15, 2015 · Recall initiated: March 25, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qualitest Pharmaceuticals
- Distributor
- Nationwide
- Lot
- Lot #: (a) L073D14A, Exp 07/31/15. Lot #: (b) L073D14B, Exp 07/31/15; 0000002247, Exp 03/31/16; L063B14A, Exp 05/31/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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