Mylan recalls
Mylan appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2017-02-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2012-12-05 to 2017-02-01 |
| By agency | FDA Drug (5) |
| By classification | Class II (5) |
| By status | terminated (5) |
| Distribution named in notices | US |
Recalls
- 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
Reason: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. - 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
Reason: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. - 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
Reason: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. - 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
Reason: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. - 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 · 2012-12-05 · Mylan
Reason: Failed USP Content Uniformity Requirements: OOS result reported on retained samples.