Exact FDA event identifier

Event 87384

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

Event summary

Timeline bucket: February 17, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: The General Hospital Corporation

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

Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50

D-0288-2021

Recall number: D-0288-2021
Initiated: February 17, 2021
Classification: Class II
Status: Terminated
Recalling firm: The General Hospital Corporation
Quantity: 50 mL vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot # P01-021721, exp 02/17/2021

Distribution pattern

Product was distributed to one direct account.