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 Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Reported: February 1, 2017 Initiated: December 20, 2016 #D-0443-2017
Product Description
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 Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
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
- a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914)
- Distribution
- Nationwide in the USA
- Location
- Caguas, PR
Frequently Asked Questions
What product was recalled? ▼
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 Pharmaceuticals, Inc., Morgantown, WV 26505 USA.. Recalled by Mylan LLC.. Units affected: a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914).
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-0443-2017.
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