Strides Pharma Recalls Potassium Chloride Tablets Due to Oversized Size
Strides Pharma Science Limited is recalling specific lots of Potassium Chloride Extended-Release Tablets because oversized tablets were found.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Strides Pharma Science Limited is voluntarily recalling 2,576 bottles of Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg). The recall affects 1,000-count bottles distributed nationwide in the United States. The specific lots involved are 7238958A and 7238257A (expiring 7/31/2021) and 7239404A (expiring 9/30/2021).
The recall was initiated because oversized tablets were identified in one lot of the product. This is a Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
Consumers who have these specific lots of Potassium Chloride tablets should stop using them and contact their pharmacist or healthcare provider for guidance. The product is prescription-only and was distributed by Strides Pharma Inc. in East Brunswick, NJ.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Strides Pharma Science Limited
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,576
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 (5)
- Lot #: 7238958A
- 7238257A
- Exp 7/31/2021
- 7239404A
- Exp 9/30/2021
UPCs (1)
- 0364380861065
Distribution
Distributed nationwide across the United States.
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