Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Potassium Chloride Extended-Release Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
Affected NDC
64380-0861-08
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 Science Limited
- NDC code
- 64380-861-08
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1029-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other failed specification recalls from 2020
All failed specification recalls
Class III · Low risk
NDC 64380-721-06 Tacrolimus Capsules
Failed Moisture Limits
Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
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