Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90257

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

Open FDA event record

Event summary

Timeline bucket
May 24, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
US Specialty Formulations 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

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

Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229

D-0986-2022
Recall number
D-0986-2022
Initiated
May 24, 2022
Classification
Class II
Status
Terminated
Quantity
781 vials

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 #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23

Distribution pattern

Product was distributed to medical facilities and a physician's office Nationwide in the USA.

drug · product 2 of 2

B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523

D-0987-2022
Recall number
D-0987-2022
Initiated
May 24, 2022
Classification
Class II
Status
Terminated
Quantity
1992 vials

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 #: 02RP1507A, exp. date 30-Jun-22; 02RP1512A, exp. date 30-Sep-22; 02RP1514A, exp. date 31-Nov-22; 02RP1515A, exp. date 31-Dec-22

Distribution pattern

Product was distributed to medical facilities and a physician's office Nationwide in the USA.