Status
Terminated
Drug Enforcement D-0262-2023
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Classification
Class II
Report Date
February 8, 2023
Termination Date
October 27, 2023
Product Information
- 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
- Product quantity
- Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles
- Reason for recall
- Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.
Location & Firm
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Address
-
2 Independence Way, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0262-2023
- Event ID
- 91500
- Recall initiation date
- January 13, 2023
- Center classification date
- February 2, 2023
- Code info
- Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.
- More code info
- —