FDA Drug recall D-066-2013
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
- FDA Drug
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 by Mylan, citing failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-066-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-29 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan |
| Distribution | n/a |
Product
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Reason
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Identifiers
| ndc | 0378-2045-01 |
|---|---|
| ndc | 0378-2046-01 |
| ndc | 0378-2047-01 |
| code_info | Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Mylan
- Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98
FDA Drug · Class II · 2017-02-01 · Mylan - Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Ph…
FDA Drug · Class II · 2017-02-01 · Mylan - Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Ph…
FDA Drug · Class II · 2017-02-01 · Mylan - Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Ph…
FDA Drug · Class II · 2017-02-01 · Mylan
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-066-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.