Reported Dec 2, 2020 · Terminated
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.…
Heritage 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: Heritage Pharmaceuticals Inc · 1 Tower Center Blvd Ste 1700 · East Brunswick, NJ · 08816-1145
Is this the product you have?
- Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only
- Distributed by
Heritage Pharmaceuticals Inc. East BrunswickNJ 08816 Made in IndiaNDC 23155-050-01
- Lot codes and dates
Lot #: 18029979Exp 1/2021
- Amount recalled
- 7176 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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