Drug product
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
D-0549-2026
Product summary
- Event
- Event 98899
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 520 syringes
- Official record key
drug-enforcement:D-0549-2026
Official wording
Reason: Presence of a Foreign Substance; black particles observed in liquid
Code information: Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026
Distribution pattern: OH
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance