Exact FDA event identifier

Event 79168

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

Event summary

Timeline bucket: January 12, 2018
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: The Compounding Pharmacy of America

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

HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892

D-0600-2018

Recall number: D-0600-2018
Initiated: January 12, 2018
Classification: Class I
Status: Terminated
Recalling firm: The Compounding Pharmacy of America
Quantity: 5 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

Lot: 01052018@46 Use By: 2/9/2018

Distribution pattern

TN, SC