Recalls / Class II
Class IID-0860-2022
Product
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
- Affected lot / code info
- Lot #: 3112743, Exp. Date 4/30/2023; 3112582, Exp. Date 3/31/2023; 3110438, 3111708, 3111120, Exp. Date 7/31/2022
Why it was recalled
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 555 cartons
- Distribution pattern
- Nationwide within USA
Timeline
- Recall initiated
- 2022-04-01
- FDA classified
- 2022-05-11
- Posted by FDA
- 2022-05-18
- Terminated
- 2023-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0860-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.