Cipla Recalls Levalbuterol Inhalation Solution Vials for Impurity Failure
Cipla Limited is recalling 140,625 vials of Levalbuterol Inhalation Solution because the product failed impurity specifications. The affected lot is distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Cipla Limited is recalling 140,625 vials of Levalbuterol Inhalation Solution, USP, 0.31 mg/3 mL. The product is a prescription-only medication manufactured by Cipla Ltd. in India for Dr. Reddy's Laboratories, Inc. The specific lot number is FA4022, with an expiration date of December 2015.
The recall was initiated because the product is out of specification for a known degradant, which is a type of impurity or degradation product. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the United States, including Puerto Rico. Patients and healthcare providers should stop using the affected vials and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
- Manufacturer
- Cipla Limited
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 140,625
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 #: FA4022
- Expiry: December 2015.
Distribution
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