Reported Feb 1, 2017 · Terminated
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC…
Mylan LLC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan LLC. · Road #156, Km. 58.8, Lot 24B · Caguas, PR · 00725
Is this the product you have?
- 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.
- Lot codes and dates
LOT #: a) 2006915Exp 02/18b) 2006914Exp 02/18
- Amount recalled
- a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
This product could cause temporary or reversible health problems — stop using it.
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