Teva Pharmaceuticals USA Inc 2023-04-12 Health moderate FDA
Health · FDA · Recall #FDA-D-0510-2023
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets,… Recall
Issued April 12, 2023 · Teva Pharmaceuticals USA Inc
In April 2023, Teva Pharmaceuticals USA Inc recalled the Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets,…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
What you should do
- 1 Stop using Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Teva Pharmaceuticals USA Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Teva Pharmaceuticals USA Inc
- Category
- Health
- Recall date
- April 12, 2023
- Units affected
- Not reported
- Sold at
- USA Nationwide
- Recall number
- FDA-D-0510-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Teva Pharmaceuticals USA Inc has 8 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.