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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92625

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2023
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Preferred 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

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

Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.

D-0894-2023
Recall number
D-0894-2023
Initiated
June 26, 2023
Classification
Class II
Status
Ongoing
Quantity
541 Bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications

Code information

Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023

Distribution pattern

Nationwide within the United States