PlainRecalls
FDA Drug Moderate Class II Terminated

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

Reported: March 15, 2017 Initiated: January 27, 2017 #D-0493-2017

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

Details

Units Affected
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
Distribution
Nationwide
Location
Rockford, IL

Frequently Asked Questions

What product was recalled?
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each).
Why was this product recalled?
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2017. Severity: Moderate. Recall number: D-0493-2017.