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.

FDA recall notice · announced June 21, 2017 · Bausch & Lomb

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 253211, Exp 12/18
Quantity: 44,520 bottles
Status: Terminated
Products in this recall event:
- 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 8 148 (D-0899-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.