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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94289

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

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Event summary

Timeline bucket
March 26, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cipla 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

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

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53

D-0471-2024
Recall number
D-0471-2024
Initiated
March 26, 2024
Classification
Class II
Status
Terminated
Recalling firm
Cipla USA, Inc.
Quantity
59244/3ml FFS packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Code information

Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025

Distribution pattern

USA nationwide.

Field note

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