Exact FDA event identifier

Event 89481

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

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Event summary

Timeline bucket: January 25, 2022
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Blaine Labs 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670

D-0668-2022

Recall number: D-0668-2022
Initiated: January 25, 2022
Classification: Class I
Status: Terminated
Recalling firm: Blaine Labs Inc
Quantity: 1119 (1 oz.) bottles/ 772 (3 oz.) tubes

App-derived interpretation

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

Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

Code information

Lot/Batch #: BL 2844, Expiration date 2/19/2023

Distribution pattern

Nationwide in 17 States to 45 doctors.