Reported Sep 3, 2014 · Terminated
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc.,…
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 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
- Lot codes and dates
- Lot 3040063 Exp. 07/14
- Amount recalled
- 2,658 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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