Wockhardt Recalls Pantaprazole Sodium Tablets Due to Dissolution Failure
Wockhardt USA is recalling 1,129 bottles of Pantaprazole Sodium 40 mg tablets because they failed dissolution specifications.
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 2/5 (Moderate).
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 the hazard involves a quality control failure (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Wockhardt USA Inc. is recalling 1,129 bottles of Pantaprazole Sodium Delayed Release Tablets, USP 40 mg. The product is distributed nationwide, including Puerto Rico. The specific lot number is DM12286, with an expiration date of 06/14.
The recall was initiated because the product failed dissolution specifications. Specifically, the 12-month acid dissolution test results were above the upper limit specifications. This indicates that the tablets may not dissolve properly over time, potentially affecting the drug's performance.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1,129
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: #: DM12286
- Expiry: 06/14.
Distribution
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