NasalCrom — Class II drug recall D-0899-2017
Terminated recall by Bausch & Lomb, Inc., reported 2017-06-21, distributed nationwide. CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this
| Recall number | D-0899-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb, Inc., Tampa, FL, United States |
| Recall initiated | 2017-06-06 |
| Classified | 2017-06-09 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 44,520 bottles |
| Reason classes | microbial contamination, cgmp |
| Lot numbers | 12/18, 253211 |
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.
Reason for recall
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0899-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.