Reported Aug 9, 2017 · Terminated
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- 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
- forWatson Laboratories, Inc., Corona, CA 92880; Mfd
- byCipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 GA60206, GA60207, Exp 08/17 2 GA60283, GA60284, Exp 09/17 3 GA60378, GA60379, GA60478, Exp 10/17 4 GA60491, Exp 11/17 5 GA60615, GA60616, Exp 12/17 6 GA60719, GA60720, GA60721, GA60749, GA60750, GA60751, Exp 01/18 7 GA70001, GA70031, GA70046, GA70047, GA70074, GA70075, Exp 06/18 - Amount recalled
- 401,750 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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