Agency classClass IIIOur severity:Low FDA (Drugs)·D-1039-2017·Announced 2017-08-09

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.

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 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: impurities
degradation
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Teva Pharmaceuticals USA

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