Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Potassium Chloride Extended-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
Affected NDC
64380-0861-07
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Potassium Chloride NDC 64380-0861 |
750 mg/1 | Tablet, Extended Release Oral |
Strides Pharma Science Limited | Rx |
- Recalling firm
- Strides Pharma Inc.
- NDC code
- 64380-861-07
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0006-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Strides Pharma Inc.
All 2021 recalls
Class II · Moderate risk
Cinacalcet Tablets 90 mg
Failed Dissolution Specifications.
Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Other dissolution failure recalls from 2021
All dissolution failure recalls
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class III · Low risk
Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
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