Qualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity
Qualitest Pharmaceuticals is recalling Promethazine VC with Codeine Syrup because a stability lot failed impurity specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, aligning with the Low severity criteria for documentation or minor specification issues.
Plain-English summary
Qualitest Pharmaceuticals is recalling Promethazine VC with Codeine Syrup, a prescription cough and cold medication. The recall involves 4 fl oz and 16 fl oz bottles manufactured for Qualitest Pharmaceuticals.
The recall was initiated because a stability lot was found to be out of specification for a known impurity at the 8-month controlled room temperature stability time-point. The affected lots are L073D14A, L073D14B, 0000002247, and L063B14A, with expiration dates ranging from May 2015 to March 2016. The product was distributed nationwide.
Consumers and healthcare providers should discontinue use of the recalled product and return it to the pharmacy or point of purchase. This is an FDA Class III recall, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- Qualitest Pharmaceuticals
- Category
- Drug — Prescription Syrup
- Hazard
- Affected units
- 36,732
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: (a) L073D14A
- Exp 07/31/15. Lot #: (b) L073D14B
- Exp 07/31/15
- 0000002247
- Exp 03/31/16
- L063B14A
- Exp 05/31/15
Distribution
Distributed nationwide across the United States.
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