D-1057-2020 Class III Terminated
FDA drug recall D-1057-2020 was initiated by Mylan Pharmaceuticals Inc. on March 23, 2020 and is designated Class III. Reason for recall: Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. The recall status is terminated (terminated July 7, 2021). Affected quantity: 3,816 botlles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 1, 2020
- Initiation Date
- March 23, 2020
- Termination Date
- July 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,816 botlles
Product Description
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Reason for Recall
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot # 3105410, 3106268, Exp 9/2020