Promethazine HCl Tablets Recalled Due to Manufacturing Temperature Deviation
McKesson Medical-Surgical is recalling Promethazine HCl Tablets, 25 mg, due to temperature deviations during manufacturing that did not comply with current good manufacturing practices. The recall affects 16 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving manufacturing process deviations with no reported illnesses or injuries. Temperature abuse during manufacturing represents a risk-of-harm to pharmaceutical efficacy without yet-reported injury, meeting the criteria for a High severity rating.
Plain-English summary
Promethazine HCl Tablets, USP, 25 mg, in 100-count unit dose boxes manufactured by Major Pharma are being recalled. McKesson Medical-Surgical Inc., the recalling firm, initiated the recall due to current good manufacturing practice (cGMP) deviations identified during manufacturing, specifically related to temperature abuse.
McKesson Medical-Surgical Inc. reports it is unable to identify which specific lot numbers were received by individual customers. The company has notified customers of the distribution dates and timeframe associated with the recalled product.
The recall involves 16 cartons, each containing 100-count unit dose blister packs, distributed nationwide in the United States.
Consumers who have questions about this recall should contact their healthcare provider or pharmacist.
The recalled product
- Product
- Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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