Drug product
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
D-0126-2020
Product summary
- Event
- Event 83835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,392 30 mL bottles
- Official record key
drug-enforcement:D-0126-2020
Official wording
Reason: Microbial Contamination of Non-Sterile Product.
Code information: Lot: WBD003 Exp. 03/21
Distribution pattern: Distributed in MI and further distributed Nationwide.
Derived failure modes
-
Microbial contamination
Microbial Contamination