Exact FDA event identifier

Event 78183

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

Event summary

Timeline bucket: September 27, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: United Pharmacy

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

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

Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417

D-0008-2018

Recall number: D-0008-2018
Initiated: September 27, 2017
Classification: Class II
Status: Terminated
Recalling firm: United Pharmacy
Quantity: 268 vials

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; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed

Code information

Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18

Distribution pattern

Nationwide.