Exact FDA event identifier

Event 64312

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 08, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Watson 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

2 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 2

Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01

D-203-2013

Recall number: D-203-2013
Initiated: February 08, 2013
Classification: Class II
Status: Terminated
Recalling firm: Watson Laboratories Inc
Quantity: 9,824 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .

Code information

386585A, Exp. 02/13; 429104A, Exp. 06/13; 474487A, Exp. 11/13; 491671A, Exp.01/14.

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 2

Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01

D-204-2013

Recall number: D-204-2013
Initiated: February 08, 2013
Classification: Class II
Status: Terminated
Recalling firm: Watson Laboratories Inc
Quantity: 20,587 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .

Code information

387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14

Distribution pattern

Nationwide and Puerto Rico