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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92616

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

Open FDA event record

Event summary

Timeline bucket
June 27, 2023
Product types
Drug
Classifications
Class I
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

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

D-0938-2023
Recall number
D-0938-2023
Initiated
June 27, 2023
Classification
Class I
Status
Terminated
Recalling firm
Cipla USA, Inc.
Quantity
278,538 canisters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Code information

Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023

Distribution pattern

Nationwide in the US