Exact FDA event identifier

Event 64963

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

Open FDA event record

Event summary

Timeline bucket: March 16, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

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

"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.

D-311-2013

Recall number: D-311-2013
Initiated: March 16, 2013
Classification: Class II
Status: Terminated
Recalling firm: Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Quantity: 13,369 bottles (12oz), 2607 bottles (26oz)

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 Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.

Code information

Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)

Distribution pattern

Nationwide