D-0493-2017 Class II Terminated
FDA drug recall D-0493-2017 was initiated by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) on January 27, 2017 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled The recall status is terminated (terminated March 15, 2019). Affected quantity: 58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each).
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2017
- Initiation Date
- January 27, 2017
- Termination Date
- March 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
Product Description
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Reason for Recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Distribution Pattern
Nationwide
Code Information
Batch #3083289; Exp. Date 12/2018