Class II
Terminated
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
This recall has been terminated (originally issued February 8, 2023).
- Recall Initiated
- January 13, 2023
- Posted
- February 8, 2023
- Recall Number
- D-0262-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.
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