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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95275

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

Open FDA event record

Event summary

Timeline bucket
September 03, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ascend Laboratories, LLC

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

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

Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.

D-0668-2024
Recall number
D-0668-2024
Initiated
September 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ascend Laboratories, LLC
Quantity
117,493 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lots 22123437, 22123438, 22123535, Exp Date 9/30/24; 22123536, 22123537, 22123538, 22123646, 22123647, Exp Date 10/31/24; 23120529, 23120530, Exp Date 1/31/25; 23120703, 23120705, Exp Date 2/28/25; 23121429, 23121726, 23122049, 23122097, Exp Date, 4/30/25; 23121984, 23121985, 23121986, Exp Date 5/31/25; 23122325, 23122329, 23122330, 23122331, Exp Date 6/30/26; 23122776, 23122852, 23122853, 23123154, 23123155, Exp Date 8/31/26; 23123458, Exp Date 9/30/26.

Distribution pattern

Nationwide in the USA and PR