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Class II: temporary or reversible health riskTerminated

Cipla Solifenacin Succinate Tablets Recall

Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla…

CIPLA · Warren, NJ

Risk level
Class II
Reported by FDA
Jul 21, 2021
Recall ID
D-0660-2021
Check your lot numberHow we source this data

Summary

Cipla recalled Solifenacin Succinate Tablets starting Jun 10, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0660-2021 on Jul 21, 2021. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.

Lot numbers, UPCs & expiration codes

Lot #: GG90819, Exp. Date 06/2021

Where it was sold

Nationwide within the United States

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-0660-2021
Classification
Class II
Status
Terminated
Recall initiated
Jun 10, 2021
FDA report date
Jul 21, 2021
Quantity
7228 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
CIPLA

Original FDA data

Every field from FDA enforcement report D-0660-2021, exactly as published.

Show all FDA fields
City
Warren
State
NJ
Status
Terminated
Country
United States
Event ID
88090
Address
10 Independence Blvd
Code information
Lot #: GG90819, Exp. Date 06/2021
Postal code
07059-2730
Report date
Jul 21, 2021
Product type
Drugs
Recall number
D-0660-2021
Classification
Class II
Recalling firm
CIPLA
Product quantity
7228 bottles
Termination date
Jan 10, 2024
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
Distribution pattern
Nationwide within the United States
Recall initiation date
Jun 10, 2021
Initial firm notification
Letter
Center classification date
Jul 15, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0660-2021, published Jul 21, 2021. 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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