TACROLIMUS

Generic: TACROLIMUS

Mylan Pharmaceuticals Inc.Manufacturer
ORALRoute
TACROLIMUSActive Substance
2010-09-17Original Approval

TACROLIMUS is FDA application ANDA090596, sponsored by MYLAN. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2020-03-23
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047

Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in

Class II2023-02-08
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle

Class III2020-12-22
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengalur

Failed Moisture Limits

Class II2012-06-29
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

Class III2022-07-11
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35,

Defective Container: Tube split from side seam

Class II2023-12-15
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally,

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrol

Top Reported Reactions

1
OFF LABEL USE
12,642 reports
2
DRUG INEFFECTIVE
8,811 reports
3
PRODUCT USE IN UNAPPROVED INDICATION
6,056 reports
4
DRUG INTERACTION
5,550 reports
5
ACUTE KIDNEY INJURY
5,393 reports
6
DIARRHOEA
4,492 reports
7
TRANSPLANT REJECTION
4,073 reports
8
CYTOMEGALOVIRUS INFECTION
4,009 reports
9
PYREXIA
3,812 reports
10
COVID-19
3,720 reports