Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Potassium Chloride Extended-Release Capsules
Class I — High risk. Reasonable probability of serious harm or death.
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 Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
Affected NDCs
68001-0396-00
68001-0396-03
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 68001-0396 |
750 mg/1 | Capsule, Extended Release Oral |
BluePoint Laboratories | Rx |
- Recalling firm
- Amerisource Health Services LLC
- NDC code
- 68001-396-00
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jun 25, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0619-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other recalls by Amerisource Health Services LLC
All 2024 recalls
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Other dissolution failure recalls from 2024
All dissolution failure recalls
Class II · Moderate risk
Colchicine Capsules 0.6 mg
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class II · Moderate risk
glipiZIDE
Failed Dissolution Specifications:
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Mycophenolic Acid Delayed-Release Tablets USP
Failed Dissolution Specifications
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