CLASS II Drug recall · Reported 21 Jun 2017 · FDA Enforcement Report
NasalCrom (cromolyn sodium) Nasal Spray recalled by Bausch & Lomb
Bausch & Lomb is recalling NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, distributed nationwide in the US. The recall was initiated on 6 Jun 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0899-2017
- FDA event ID
- 77391
- Recalling firm
- Bausch & Lomb, Tampa, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2017
- FDA classified
- 9 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Nasal Sprays
Timeline
| 6 Jun 2017 | Recall initiated by company | |
| 9 Jun 2017 | Classified by FDA | +3 days |
| 21 Jun 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Which lots are affected?
Lot: 253211, Exp 12/18
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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