Teva Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
Teva Pharmaceuticals USA is recalling Albuterol Sulfate Inhalation Solution because high levels of a related compound were detected.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues without reported harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton. The product is manufactured for Watson Laboratories, Inc., and manufactured by Cipla Ltd. The recall involves 401,750 cartons distributed nationwide in the USA and Puerto Rico.
The recall was initiated because the product failed impurities and degradation specifications, specifically showing high out-of-specification results for related compound D. The affected lots include GA60206, GA60207, GA60283, GA60284, GA60378, GA60379, GA60478, GA60491, GA60615, GA60616, GA60719, GA60720, GA60721, GA60749, GA60750, GA60751, GA70001, GA70031, GA70046, GA70047, GA70074, and GA70075, with expiration dates ranging from August 2017 to June 2018.
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Patients and healthcare providers should check their inventory for the specific lot numbers listed and contact Teva Pharmaceuticals USA or their healthcare provider for further instructions.
The recalled product
- Product
- Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 401,750
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 (20)
- Lot #s: GA60206
- GA60207
- Exp 08/17
- GA60283
- GA60284
- Exp 09/17
- GA60378
- GA60379
- GA60478
- Exp 10/17
- GA60491
- Exp 11/17
- GA60615
- GA60616
- Exp 12/17
- GA60719
- GA60720
- GA60721
- GA60749
- GA60750
Distribution
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