Cipla Solifenacin Succinate Tablets Recalled for CGMP Deviations
Cipla USA is recalling 7,228 bottles of Solifenacin Succinate Tablets, 10 mg (Lot #GG90819, expiring 06/2021) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall initiated voluntarily by the firm for CGMP deviations. The source text states no illnesses or injuries have been reported. CGMP violations represent a manufacturing process deviation rather than an imminent hazard with reported harm, making this a moderate-severity precautionary action.
Plain-English summary
Cipla USA, Inc. is voluntarily recalling 7,228 bottles of Solifenacin Succinate Tablets, 10 mg (NDC 69097-261-02) distributed nationwide within the United States. The affected product is from Lot #GG90819 with an expiration date of 06/2021 and was manufactured by Cipla Ltd. in Verna, Goa, India.
The recall was initiated by the firm on June 10, 2021, due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. CGMP violations indicate that the manufacturing conditions and processes did not meet FDA standards for drug production.
Patients taking this medication should consult their healthcare provider or pharmacist regarding continued use. Consumers who have this product should not use it and should contact their pharmacy or healthcare provider for further guidance. The recall was terminated on January 10, 2024.
The recalled product
- Product
- 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.
- Manufacturer
- CIPLA
- Affected units
- 7,228
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: GG90819
- Exp. Date 06/2021
Distribution
Distributed nationwide across the United States.
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