Pantoprazole Sodium Delayed-Release Tablets Recalled Nationwide Due to Manufacturing Cracking Defect
Torrent Pharma Inc is recalling 24,888 bottles of Pantoprazole Sodium 20 mg tablets nationwide due to manufacturing defects causing tablets to crack within bottles.
What this means for you
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: FDA Class II recall for manufacturing defect affecting product integrity in a prescription medication. Cracked tablets represent a risk-of-harm product, meeting the High severity threshold per the rubric criteria.
Plain-English summary
Torrent Pharma Inc is recalling 24,888 bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg (NDC 13668-096-90) distributed nationwide in the United States. The recall addresses Current Good Manufacturing Practice (CGMP) deviations.
The specific defect identified is tablets cracking within the bottles. The affected lots are BA34G021 and BA34G022, with expiration date September 2022.
Consumers with affected product should consult their pharmacy or healthcare provider.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug
- Hazard
- tablet-cracking
- manufacturing-defect
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 (3)
- Lot #s: BA34G021
- BA34G022
- Exp. 09/2022
UPCs (2)
- 0313668096903
- 0313668429305
Distribution
Distributed nationwide across the United States.
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