Drug product
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
D-0506-2025
Product summary
- Event
- Event 97031
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 695,880 cartons
- Official record key
drug-enforcement:D-0506-2025
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Code information: All Lots.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Microbial contamination
Microbial Contamination