HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Lt
Summary
The FDA issued a Class II for HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, M by SKY PACKAGING. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0219-2025
Action Date
2025-02-12
Status
Ongoing
Category
drug
Product Description
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
Lot/Code Info: Lot #: 0000127312, Exp. Date 31-Mar-2025; 0000127576, 0000127577, Exp. Date 31-Jul-2025; 0000128204, Exp. Date 31-Dec-2025; 0000128358, Exp. Date 31-Jan-2026
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-24
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SKY PACKAGING has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SKY PACKAGING) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SKY PACKAGING have FDA actions?
SKY PACKAGING has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0219-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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