Recalls / Class II
Class IID-0001-2021
Product
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Oral
- NDCs
- 64380-860, 64380-861
- FDA application
- ANDA210733
- Affected lot / code info
- 7240675A; Exp. 12/31/2021
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Strides Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 S Main St Ste 3, N/A, Lambertville, New Jersey 08530-1859
Distribution
- Quantity
- 11,280 bottles
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2020-08-24
- FDA classified
- 2020-10-01
- Posted by FDA
- 2020-10-07
- Terminated
- 2022-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0001-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.