Teva Pharmaceuticals USA Inc 2023-07-19 Health serious FDA
Health · FDA · Recall #FDA-D-0913-2023
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva… Recall
Issued July 19, 2023 · Teva Pharmaceuticals USA Inc
In July 2023, Teva Pharmaceuticals USA Inc recalled the Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
What you should do
- 1 Stop using Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva… 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
- July 19, 2023
- Units affected
- Not reported
- Sold at
- Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
- Recall number
- FDA-D-0913-2023
- 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.