D-0262-2023 Class II Terminated
FDA drug recall D-0262-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on January 13, 2023 and is designated Class II. Reason for recall: Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory. The recall status is terminated (terminated October 27, 2023). Affected quantity: Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; .
Recall Details
- Product Type
- Drugs
- Report Date
- February 8, 2023
- Initiation Date
- January 13, 2023
- Termination Date
- October 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles
Product Description
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.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.