Drug recall D-0262-2023
Product
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81
Reason for recall
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Lots and codes
Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 13, 2023
- Terminated
- October 27, 2023
Related products
- Diltiazem Hydrochloride – drug information
- NDC 47335-676 Diltiazem Hydrochloride · Diltiazem Hydrochloride 180 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-677 Diltiazem Hydrochloride · Diltiazem Hydrochloride 240 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-678 Diltiazem Hydrochloride · Diltiazem Hydrochloride 300 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-675 Diltiazem Hydrochloride · Diltiazem Hydrochloride 120 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-679 Diltiazem Hydrochloride · Diltiazem Hydrochloride 360 mg/1 · Sun Pharmaceutical Industries, Inc.