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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77391

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 06, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bausch & Lomb, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0899-2017
Recall number
D-0899-2017
Initiated
June 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb, Inc.
Quantity
44,520 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.

Code information

Lot: 253211, Exp 12/18

Distribution pattern

Nationwide in the USA