Rockford, IL, United States
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls
4 recalls recorded since 2018, most recently on 1 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 1 April 2022
- Terminated
- 9 June 2023
- Reason
- Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
- Distribution
- Nationwide within USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0860-2022, D-0861-2022
- 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 U
- Esomeprazole Magnesium Delayed-Release Capsules, USP 40 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 U
Terminated Class II Drugs
- Recall started
- 18 January 2019
- Terminated
- 29 April 2020
- Reason
- Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1013-2019
- Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
Terminated Class III Drugs
- Recall started
- 14 August 2018
- Terminated
- 26 June 2020
- Reason
- Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1112-2018
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Terminated Class II Drugs
- Recall started
- 1 May 2018
- Terminated
- 10 March 2021
- Reason
- GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0823-2018, D-0822-2018
- Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
- Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.