Actavis Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
Actavis Inc is recalling specific lots of Albuterol Sulfate Inhalation Solution because the product failed impurity specifications for a known degradant.
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 source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Actavis Inc is voluntarily recalling 164,844 units of Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials. The product is manufactured for Watson Laboratories Inc. and by Cipla Ltd. The recall covers lots GA51265, GA51454, GA51553, GA51583, GA51598, GA51724, GA51725, and GA51749, with expiration dates ranging from January 2017 to March 2017.
The recall was initiated because the product is out of specification for a known degradant. This is a Class III recall, which indicates that the use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the US. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for credit or disposal, as directed by the recalling firm.
The recalled product
- Product
- Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
- Manufacturer
- Actavis Inc
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 164,844
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 (11)
- Lot #: GA51265
- Ex[p. Jan-2017
- GA51454
- GA51553
- GA51583
- Exp. Feb-2017
- GA51598
- GA51724
- GA51725
- GA51749
- Exp. Mar-2017
Distribution
Distributed nationwide across the United States.
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