Amneal Pharmaceuticals of New York, LLC 2023-06-21 Health serious FDA
Health · FDA · Recall #FDA-D-0876-2023
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle,… Recall
Issued June 21, 2023 · Amneal Pharmaceuticals of New York, LLC
In June 2023, Amneal Pharmaceuticals of New York, LLC recalled the Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
What you should do
- 1 Stop using Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Amneal Pharmaceuticals of New York, LLC 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
- Amneal Pharmaceuticals of New York, LLC
- Category
- Health
- Recall date
- June 21, 2023
- Units affected
- Not reported
- Sold at
- LA, PA and OH.
- Recall number
- FDA-D-0876-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Amneal Pharmaceuticals of New York, LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.