FDA Drug Class II — Moderate

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.

Hazard

CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.

Products

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 14
Brand
Bausch & Lomb, Inc.
UPC
Lot: 253211, Exp 12/18

Units Affected

44,520 bottles