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Recall Observatory FDA recall evidence

Drug 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

D-0262-2023

January 13, 2023

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 91500
Status
Terminated
Classification
Class II
Quantity
Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles
Official record key
drug-enforcement:D-0262-2023

Official wording

Reason: Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Code information: Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.