Exact FDA event identifier

Event 68722

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

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Event summary

Timeline bucket: June 20, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Novel Laboratories, 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

Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.

D-1484-2014

Recall number: D-1484-2014
Initiated: June 20, 2014
Classification: Class III
Status: Terminated
Recalling firm: Novel Laboratories, Inc.
Quantity: 25,776 containers

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specification

These labels are deterministic app interpretations, not FDA categories.

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Reason for recall

Failed Impurity/Degradation Specification; 12-month stability time point

Code information

Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.

Distribution pattern

Nationwide