D-0899-2017 Class II Terminated
FDA drug recall D-0899-2017 was initiated by Bausch & Lomb, Inc. on June 6, 2017 and is designated Class II. Reason for recall: CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot. The recall status is terminated (terminated May 1, 2019). Affected quantity: 44,520 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 21, 2017
- Initiation Date
- June 6, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,520 bottles
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot: 253211, Exp 12/18