FDA recall D-0899-2017

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-06-06

Report date

2017-06-21

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0899-2017