Drug product
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7.
D-0899-2017
Product summary
- Event
- Event 77391
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44,520 bottles
- Official record key
drug-enforcement:D-0899-2017
Official wording
Reason: CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Code information: Lot: 253211, Exp 12/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
microbial contamination