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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85186

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

Open FDA event record

Event summary

Timeline bucket
January 24, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Breckenridge Pharmaceutical, 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

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

Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA

D-1050-2020
Recall number
D-1050-2020
Initiated
January 24, 2020
Classification
Class II
Status
Terminated
Quantity
11,250 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.

Code information

Lot #: a) 81244, 81217, Exp. Date 01/2021 and b) 81245, Exp. Date 01/2021

Distribution pattern

Product was distributed nationwide within the United States.

drug · product 2 of 2

Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA

D-1051-2020
Recall number
D-1051-2020
Initiated
January 24, 2020
Classification
Class II
Status
Terminated
Quantity
11, 250 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.

Code information

Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021

Distribution pattern

Product was distributed nationwide within the United States.