Reported Apr 15, 2015 · Terminated
PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg,…
Qualitest Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216
Is this the product you have?
- PROMETHAZINE VC WITH CODEINE SYRUP
- EACH 5 ml containsCodeine 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
- Lot codes and dates
Lot #: (a) L073D14AExp 07/31/15. Lot #: (b) L073D14BExp 07/31/150000002247Exp 03/31/16L063B14AExp 05/31/15
- Amount recalled
- 36,732 units
Where it was sold
- 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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