Qualitest Recalls Promethazine DM Syrup Due to Plastic Particulates
Qualitest Pharmaceuticals is recalling 972 bottles of Promethazine DM Syrup because plastic cap closure particulates may be present in the product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves the presence of foreign substance (plastic particulates) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Qualitest Pharmaceuticals is recalling 972 bottles of Promethazine DM Syrup, NDC 0603-1586-58. The affected product is Lot # 0000001099 with an expiration date of 03/16. The recall was initiated because plastic cap closure particulates may be present in the product.
The recalled product was distributed nationwide. Each 5 ml (one teaspoonful) of the syrup contains Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, and 7% alcohol. The product is available by prescription only.
Consumers with this product should contact their healthcare provider or pharmacist for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PH
- Manufacturer
- Qualitest Pharmaceuticals
- Category
- Drug — Prescription Syrup
- Hazard
- Affected units
- 972
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 (2)
- Lot #: 0000001099
- Exp. 03/16
Distribution
Distributed nationwide across the United States.
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