FDAFDA · Food and drugs·Recall number D-0262-2023
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
Published February 8, 2023 · Recall initiated: January 13, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the U.S.
- UPC
- 0347335679830
- Lot
- Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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