CLASS II Drug recall · Reported 7 Oct 2020 · FDA Enforcement Report
Pharma Inc.Potassium Chloride Extended-Release Tablets recalled
Strides is recalling Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg), distributed nationwide in the US. The recall was initiated on 24 Aug 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0001-2021
- FDA event ID
- 86283
- Recalling firm
- Strides, Lambertville, NJ
- Brand
- Potassium Chloride
- Manufacturer
- Strides Pharma Science Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2020
- FDA classified
- 1 Oct 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Aug 2020 | Recall initiated by company | |
| 1 Oct 2020 | Classified by FDA | +38 days |
| 7 Oct 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Is Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) recalled?
Yes. Strides recalled Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) on 24 Aug 2020. The recall is Class II and its status is Terminated. Recall number D-0001-2021.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
7240675A; Exp. 12/31/2021
Where was it sold?
nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Potassium Chloride recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride | ICU Medical | Labeling Errors | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride | ICU Medical | Other | Nationwide |
| Drug | CLASS II | Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride | The Harvard Drug Group | Potency & Assay | Nationwide |