NasalCrom Nasal Spray recalled over manufacturing violations
- Recall date
- June 6, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bausch & Lomb, Inc. recalls NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pu…
- Recall number
- D-0899-2017
- FDA classification
- Class II
- Brand / firm
- Bausch & Lomb, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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