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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88662

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

Open FDA event record

Event summary

Timeline bucket
June 30, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Promise Pharmacy, LLC

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

MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS

D-0803-2021
Recall number
D-0803-2021
Initiated
June 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Promise Pharmacy, LLC
Quantity
57 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

Code information

Lot# 06152021@2, Exp 09/13/2021

Distribution pattern

AZ, CO, FL, IL, NJ