Bausch & Lomb Recalls NasalCrom Nasal Spray Due to Potential Microbial Contamination
Bausch & Lomb is recalling specific lots of NasalCrom nasal spray due to potential microbial contamination in the manufacturing water.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as microbial contamination in a sterile product corresponds to a 'Severe' rating (Score 4), particularly given the potential for serious injury from infection.
Plain-English summary
Bausch & Lomb, Inc. is recalling 44,520 bottles of NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray. The affected product is identified by Lot 253211 and an expiration date of 12/18. The product was distributed nationwide in the USA by Medtech Products, Inc.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, there is a possibility of microbial contamination in the water used to manufacture this specific product lot.
Consumers should check their NasalCrom nasal spray bottles for Lot 253211 and an expiration date of 12/18. If the product matches these details, consumers should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- 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.
- Manufacturer
- Bausch & Lomb, Inc.
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 44,520
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 253211
- Exp 12/18
Distribution
Distributed nationwide across the United States.
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