Cipla Recalls Nevirapine Extended Release Tablets for Dissolution Failure
Cipla Limited is recalling 4,800 bottles of Nevirapine Extended Release Tablets, 400 mg, because they failed to meet dissolution specifications.
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: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a contamination or mislabeling of a common allergen.
Plain-English summary
Cipla Limited is voluntarily recalling 4,800 bottles of Nevirapine Extended Release Tablets, 400 mg, 30-count. The product is prescription-only and was manufactured by Cipla Ltd. in Verna Goa, India, for Cipla USA Inc. in Miami, Florida. The specific lot number is GG80257, with an expiration date of 12/2019.
The recall was initiated because the affected tablets failed to meet required dissolution specifications. Dissolution is a critical quality attribute that ensures the medication releases its active ingredient at the proper rate in the body. Failure to meet these specifications may result in the medication not working as intended.
The affected product was distributed nationwide within the United States. Patients and healthcare providers should stop using the recalled lot and contact their healthcare provider or pharmacist for a replacement or alternative treatment. Consumers should not return the product to the pharmacy unless instructed to do so by the recalling firm or regulatory authorities.
The recalled product
- Product
- Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
- Manufacturer
- Cipla Limited
- Category
- Drug — Antiretroviral
- Hazard
- Affected units
- 4,800
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 #: GG80257
- Exp. 12/2019
Distribution
Distributed nationwide across the United States.
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