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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62383

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

Open FDA event record

Event summary

Timeline bucket
April 17, 2012
Product types
Drug
Classifications
Class III
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

Complete imported group

Every recalled product in this event

5 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 5

Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.

D-1399-2012
Recall number
D-1399-2012
Initiated
April 17, 2012
Classification
Class III
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
8254 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Code information

Lot 108094A

Distribution pattern

Nationwide.

drug · product 2 of 5

Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01

D-1400-2012
Recall number
D-1400-2012
Initiated
April 17, 2012
Classification
Class III
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
106,323 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Code information

Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.

Distribution pattern

Nationwide.

drug · product 3 of 5

Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01

D-1401-2012
Recall number
D-1401-2012
Initiated
April 17, 2012
Classification
Class III
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
21,572 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Code information

Lot #s: 101696A, 110829A, 123685A, 123687A

Distribution pattern

Nationwide.

drug · product 4 of 5

Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01

D-1402-2012
Recall number
D-1402-2012
Initiated
April 17, 2012
Classification
Class III
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
18,902 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Code information

Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A

Distribution pattern

Nationwide.

drug · product 5 of 5

Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01

D-1403-2012
Recall number
D-1403-2012
Initiated
April 17, 2012
Classification
Class III
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
7,262 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Code information

Lot # 22478A

Distribution pattern

Nationwide.