Reported Nov 30, 2016 · Terminated
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC…
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 CapsulesUSP 120 mg100-count bottle (NDC 0378-5220-01)500-count bottle (NDC 0378-5220-05)Rx Only
- Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
- Lot codes and dates
0378-5220-01 Lot# 3065133Exp. 03/17 0378-5220-01 Lot# 3066564Exp. 05/17 0378-5220-05 Lot# 3066564Exp. 05/17 0378-5220-01 Lot# 3069645Exp. 08/17 0378-5220-05 Lot# 3069645Exp. 08/17
- Amount recalled
- 51,983 extended release capsules
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: OOS results for known compound.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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