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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77615

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

Open FDA event record

Event summary

Timeline bucket
June 05, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Apothecary By Design

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

Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.

D-0924-2017
Recall number
D-0924-2017
Initiated
June 05, 2017
Classification
Class II
Status
Terminated
Recalling firm
Apothecary By Design
Quantity
25 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.

Code information

Lot #: 04192017@1, Exp 09/30/2017

Distribution pattern

Nationwide in the USA