Reported Aug 29, 2018 · Terminated
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx…
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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 Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201
Is this the product you have?
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only
- Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
- Lot codes and dates
- Batch 3096049
- Amount recalled
- 408 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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