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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90920

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

Open FDA event record

Event summary

Timeline bucket
September 29, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CIPLA

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

Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.

D-1550-2022
Recall number
D-1550-2022
Initiated
September 29, 2022
Classification
Class II
Status
Terminated
Recalling firm
CIPLA
Quantity
9041 cartons

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: environmental monitoring failure.

Code information

Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023

Distribution pattern

Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.