D-1057-2020 Class III Terminated
FDA drug recall D-1057-2020 was initiated by Mylan Pharmaceuticals Inc. on Mar 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 Jul 7, 2021). Affected quantity: 3,816 botlles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 1, 2020
- Initiation Date
- Mar 23, 2020
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1057-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026