Status
Ongoing
Drug Enforcement D-0219-2025
Failed Impurities/Degradation Specifications
Classification
Class II
Report Date
February 12, 2025
Termination Date
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Product Information
- 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
- Product quantity
- —
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- SKY PACKAGING
- Address
-
4835 Crumpler Rd Ste B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0219-2025
- Event ID
- 96159
- Recall initiation date
- January 24, 2025
- Center classification date
- February 4, 2025
- 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
- More code info
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