Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
PROMETHAZINE VC WITH CODEINE SYRUP Recalled by Qualitest Pharmaceuticals Due to Failed Impurities/Degradation Specifications: A stability lot was out...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Qualitest Pharmaceuticals directly.
Affected Products
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.
Quantity: 36,732 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Qualitest Pharmaceuticals
Qualitest Pharmaceuticals has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report