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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

CIPLA: Solifenacin Succinate Tablets Recalled for Quality Standards Deviations

Agency Publication Date: July 15, 2021
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Summary

Approximately 7,228 bottles of Solifenacin Succinate Tablets (10 mg, 30-count) are being recalled because they were manufactured in violation of Current Good Manufacturing Practice (CGMP) standards. Solifenacin Succinate is a prescription medication used to treat overactive bladder. The recall was initiated because deviations in the manufacturing process mean the product may not meet its required quality and safety standards. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lot.

Risk

Manufacturing deviations can lead to inconsistent drug quality, potency, or purity, which may affect the medication's effectiveness or safety. While no specific injuries were reported, products not made according to CGMP standards are considered legally adulterated.

What You Should Do

  1. Check your prescription bottle for Solifenacin Succinate Tablets (10 mg, 30-count) with NDC number 69097-261-02.
  2. Verify if your bottle belongs to Lot number GG90819 with an expiration date of 06/2021.
  3. If your medication matches this lot number and expiration date, contact your healthcare provider or pharmacist immediately for guidance on whether to continue use and how to obtain a replacement.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund.
  5. Contact the manufacturer, Cipla, at their Warren, New Jersey location or through your pharmacy for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return to pharmacy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Solifenacin Succinate Tablets (10 mg, 30-count)
Model:
NDC 69097-261-02
Recall #: D-0660-2021
Lot Numbers:
GG90819 (Exp. 06/2021)
Date Ranges: Expiration Date 06/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88090
Status: Resolved
Manufacturer: CIPLA
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 7228 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.