Drug product
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
D-0619-2026
Product summary
- Event
- Event 99131
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 6564 bottles
- Official record key
drug-enforcement:D-0619-2026
Official wording
Reason: Presence of foreign substance
Code information: Lot S25133A
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
foreign substance