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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94922

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2024
Product types
Drug
Classifications
Class III
Statuses
Completed
Recalling firm wording
Zydus Pharmaceuticals (USA) 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

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).

D-0595-2024
Recall number
D-0595-2024
Initiated
July 02, 2024
Classification
Class III
Status
Completed
Quantity
12720 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination with other products

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products

Code information

Lot #: L300220, Exp. 05/31/2025.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 2 of 2

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).

D-0596-2024
Recall number
D-0596-2024
Initiated
July 02, 2024
Classification
Class III
Status
Completed
Quantity
n/a

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination with other products

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products

Code information

Lot #: L300217, Exp. 04/31/2025.

Distribution pattern

Nationwide in the USA and Puerto Rico