Reported Feb 27, 2019 · Terminated
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b)…
Mylan Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only
- Manufactured byMylan Pharmaceuticals Inc. Morgantown, WV, 26505
- Lot codes and dates
Lot #: 3090167Exp. October 2019
- Amount recalled
- 8,159 bottles
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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