Food, drugs, devices › Actavis Inc
Drug recall: Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories In
FDA enforcement event 76229 is a drug recall by Actavis Inc of Parsippany, NJ, initiated 12 Jan 2017 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 30% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 5 Mar 2018. Initiation: voluntary: firm initiated. Actavis Inc has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Actavis Inc, Parsippany, NJ.
Reason for recall
"Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant."
Distribution
"Nationwide in the US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0439-2017 | 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 | 164,844 units | Class III | Terminated | 1 Feb 2017 |
Context
Other enforcement events for Actavis Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the US"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Mar 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.