Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 2022-05-18 Health serious FDA
Health · FDA · Recall #FDA-D-0860-2022
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister… Recall
Issued May 18, 2022 · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
In May 2022, Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalled the Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
What you should do
- 1 Stop using Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 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
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Category
- Health
- Recall date
- May 18, 2022
- Units affected
- Not reported
- Sold at
- Nationwide within USA
- Recall number
- FDA-D-0860-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.