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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76395

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

Open FDA event record

Event summary

Timeline bucket
February 03, 2017
Product types
Drug
Classifications
Class I
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

7 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 7

Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40

D-0639-2017
Recall number
D-0639-2017
Initiated
February 03, 2017
Classification
Class I
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
50 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information

Lot: 20161221@70, Exp 02/04/2017

Distribution pattern

U.S. Nationwide

drug · product 2 of 7

Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59

D-0640-2017
Recall number
D-0640-2017
Initiated
February 03, 2017
Classification
Class I
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
386 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information

Lot: 20161228@65, Exp 02/26/2017; Lot: 20161214@76, Exp 02/12/2017

Distribution pattern

U.S. Nationwide

drug · product 3 of 7

Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59

D-0641-2017
Recall number
D-0641-2017
Initiated
February 03, 2017
Classification
Class I
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
716 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information

Lot: 20161213@23, Exp 2/11/2017; Lot: 20161214@80, Exp 2/12/2017; Lot: 20161215@1, Exp 2/13/2017

Distribution pattern

U.S. Nationwide

drug · product 4 of 7

Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59

D-0642-2017
Recall number
D-0642-2017
Initiated
February 03, 2017
Classification
Class I
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
490 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information

Lot: 20161212@44, Exp 2/10/2017; Lot: 20161230@40, Exp 2/28/2017

Distribution pattern

U.S. Nationwide

drug · product 5 of 7

Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44

D-0643-2017
Recall number
D-0643-2017
Initiated
February 03, 2017
Classification
Class I
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
50 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information

Lot: 20161221@74, Exp 2/4/2017

Distribution pattern

U.S. Nationwide

drug · product 6 of 7

Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40

D-0644-2017
Recall number
D-0644-2017
Initiated
February 03, 2017
Classification
Class I
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
30 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information

Lot: 20161222@8, Exp 2/5/2017

Distribution pattern

U.S. Nationwide

drug · product 7 of 7

Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40

D-0645-2017
Recall number
D-0645-2017
Initiated
February 03, 2017
Classification
Class I
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
62 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information

Lot: 20161219@3, Exp 2/2/2017

Distribution pattern

U.S. Nationwide

Field note

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