Exact FDA event identifier

Event 88289

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

Event summary

Timeline bucket: July 15, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: API Solutions 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01

D-0695-2021

Recall number: D-0695-2021
Initiated: July 15, 2021
Classification: Class II
Status: Terminated
Recalling firm: API Solutions Inc.
Quantity: 20 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: ETL181001, Exp 10/09/2021

Distribution pattern

AL, AZ, CO, FL, VA

drug · product 2 of 2

Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York

D-0696-2021

Recall number: D-0696-2021
Initiated: July 15, 2021
Classification: Class II
Status: Terminated
Recalling firm: API Solutions Inc.
Quantity: 1 bottle

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: AZA181105, Exp 11/09/2021

Distribution pattern

AL, AZ, CO, FL, VA