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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80553

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

Open FDA event record

Event summary

Timeline bucket
July 18, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
VENSUN PHARMACEUTICALS 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

Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.

D-1017-2018
Recall number
D-1017-2018
Initiated
July 18, 2018
Classification
Class II
Status
Terminated
Quantity
11,652 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Tablet breakage

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Tablet breakage

Code information

Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.

Distribution pattern

Within the United States and Puerto Rico.

drug · product 2 of 2

Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.

D-1018-2018
Recall number
D-1018-2018
Initiated
July 18, 2018
Classification
Class II
Status
Terminated
Quantity
3,683 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Tablet breakage

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Tablet breakage

Code information

Lot #: 9570012, Exp. June-2019

Distribution pattern

Within the United States and Puerto Rico.