Zydus Recalls Promethazine Hydrochloride Tablets Due to Foreign Tablet Presence
Zydus Pharmaceuticals USA Inc. is recalling 10,200 bottles of Promethazine Hydrochloride 25 mg tablets because atenolol 25 mg tablets were found mixed into the bottles.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as medication mix-ups that could lead to adverse health consequences.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 10,200 bottles of Promethazine Hydrochloride Tablets, USP, 25 mg. The product is distributed nationwide and was manufactured by Cadila Healthcare Ltd. in India. The specific lot affected is MN9081, with an expiration date of 09/2015.
The recall was initiated due to the presence of foreign tablets. Specifically, atenolol 25 mg tablets were found mixed into the promethazine 25 mg tablet bottles. This constitutes a mix-up of two different prescription medications.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
- Brand
- PROMETHAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Affected units
- 10,200
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 #: MN9081
- Expiry: 09/2015
Distribution
Distributed nationwide across the United States.
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