Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
Reported: February 1, 2017 Initiated: December 20, 2016 #D-0444-2017
Product Description
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
Reason for Recall
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Details
- Recalling Firm
- Mylan LLC.
- Units Affected
- 588 bottles
- Distribution
- Nationwide in the USA
- Location
- Caguas, PR
Frequently Asked Questions
What product was recalled? ▼
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.. Recalled by Mylan LLC.. Units affected: 588 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2017. Severity: Moderate. Recall number: D-0444-2017.
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