Drug product
NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
D-0437-2023
Product summary
- Event
- Event 91708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,974
- Official record key
drug-enforcement:D-0437-2023
Official wording
Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Code information: Lot: 221263, Exp: 10/24; 222047, 222048 Exp: 02/25; 222099, 222100, Exp: 03/25
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations