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Class II: temporary or reversible health riskTerminated

Strides Pharma Inc Recall

Strides Pharma Inc

Strides Inc. · Lambertville, NJ

Risk level
Class II
Reported by FDA
Oct 7, 2020
Recall ID
D-0001-2021
Check your lot numberHow we source this data

Summary

Strides recalled Strides Pharma Inc starting Aug 24, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0001-2021 on Oct 7, 2020. Reason: Failed Dissolution Specifications. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications

Product description

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

Lot numbers, UPCs & expiration codes

7240675A; Exp. 12/31/2021

Where it was sold

nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0001-2021
Classification
Class II
Status
Terminated
Recall initiated
Aug 24, 2020
FDA report date
Oct 7, 2020
Quantity
11,280 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Strides Inc.

Original FDA data

Every field from FDA enforcement report D-0001-2021, exactly as published.

Show all FDA fields
City
Lambertville
State
NJ
Status
Terminated
Country
United States
Event ID
86283
Address
201 S Main St Ste 3
Code information
7240675A; Exp. 12/31/2021
Postal code
08530-1859
Report date
Oct 7, 2020
Product type
Drugs
Recall number
D-0001-2021
Classification
Class II
Recalling firm
Strides Inc.
Product quantity
11,280 bottles
Termination date
Jan 11, 2022
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
nationwide
Recall initiation date
Aug 24, 2020
Initial firm notification
Letter
Center classification date
Oct 1, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0001-2021, published Oct 7, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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