Reported Feb 8, 2023 · Terminated
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles
- Manufactured bySun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India
- Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81
- Lot codes and dates
Lot #: HAC3120AHAC3121AExp. 04/2023HAC4460AExp. 10/2023HAD0365AExp. 12/2023HAD1452AExp. 02/2024
- Amount recalled
- Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
This product could cause temporary or reversible health problems — stop using it.
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