Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot: 253211, Exp 12/18
Why it was recalled
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Recalling firm
- Firm
- Bausch & Lomb, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, N/A, Tampa, Florida 33637-1014
Distribution
- Quantity
- 44,520 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-06-06
- FDA classified
- 2017-06-09
- Posted by FDA
- 2017-06-21
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0899-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.