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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90080

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

Open FDA event record

Event summary

Timeline bucket
April 25, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SCA Pharmaceuticals

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

3 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 3

Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40

D-0829-2022
Recall number
D-0829-2022
Initiated
April 25, 2022
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
120 bags

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

Code information

Lot #: 1222035815, Exp. Date 10-Jul-22

Distribution pattern

Product was distributed nationwide within the United States

drug · product 2 of 3

Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32

D-0830-2022
Recall number
D-0830-2022
Initiated
April 25, 2022
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
424 bags

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

Code information

Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22

Distribution pattern

Product was distributed nationwide within the United States

drug · product 3 of 3

Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44

D-0831-2022
Recall number
D-0831-2022
Initiated
April 25, 2022
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
30 bags

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

Code information

Lot #: 1222035839, Exp. Date 09-Aug-22

Distribution pattern

Product was distributed nationwide within the United States