FDAHealthJanuary 24, 2025
SKY PACKAGING — HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba S
⚠️ Failed Impurities/Degradation Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 24, 2025
Nationwide within the United States
What's affected?
- Product
- HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
- Brand
- SKY PACKAGING
- Lot code
- 0000127410
Additional details
Lot #: 0000127410, 63739-328-10, Exp. Date 30-Apr-2025; 0000127579, Exp. Date 31-Aug-2025; 0000128245, Exp. Date 31-Dec-2025; 0000128486, Exp. Date 28-Feb-2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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