PlainRecalls
FDA Drug Low Class III Terminated

Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01

Reported: April 1, 2020 Initiated: March 23, 2020 #D-1057-2020

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.

Details

Units Affected
3,816 botlles
Distribution
U.S.A. Nationwide
Location
Morgantown, WV

Frequently Asked Questions

What product was recalled?
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 3,816 botlles.
Why was this product recalled?
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 1, 2020. Severity: Low. Recall number: D-1057-2020.