Class II · Moderate risk
Vumerity (diroximel fumarate)
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Strides Pharma Inc.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
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
Affected NDC
64380-0860-06
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 64380-0860 |
600 mg/1 | Tablet, Extended Release Oral |
Strides Pharma Science Limited | Rx |
- Recalling firm
- Strides Inc.
- NDC code
- 64380-860-06
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0001-2021 · 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 dissolution failure recalls from 2020
All dissolution failure recalls
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Failed Dissolution Specifications
Class I · High risk
Anagrelide Capsules
Failed Dissolution Specifications
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