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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91749

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nephron Sterile Compounding Center 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

8 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 8

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.

D-0355-2023
Recall number
D-0355-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
4,743 bottles

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

Lots: DS2053, Exp. 2/27/2023

Distribution pattern

Nationwide in the USA

drug · product 2 of 8

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.

D-0356-2023
Recall number
D-0356-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
443,483 bottles

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

Lots: NB2015A, Exp. 02/27/2023; NB2016A, Exp. 02/19/2023; NB2021A, Exp. 03/05/2023; NB2023A, Exp. 03/12/2023; NB2026A, Exp. 03/29/2023; NB2029A, Exp. 04/21/2023; NB2031A, Exp. 04/21/2023; NB2033A, Exp. 05/10/2023; NB2034A, Exp. 05/19/2023; NB2037A, Exp. 05/25/2023; NB2039A, Exp. 06/05/2023; NB2041A, Exp. 06/14/2023; NB2044A, Exp. 06/18/2023; NB2050A, Exp. 07/19/2023; NB2054A, Exp. 08/04/2023; NB2057A, Exp. 08/12/2023; NB2059A, Exp. 08/20/2023; NB2061A, Exp. 09/14/2023; NB2067A, Exp. 09/22/2023

Distribution pattern

Nationwide in the USA

drug · product 3 of 8

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.

D-0357-2023
Recall number
D-0357-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
305,895 bottles

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

Lots: NB2017A, Exp. 03/04/2023; NB2019A, Exp. 02/21/2023; NB2024A, Exp. 03/27/2023; NB2025A, Exp. 03/24/2023; NB2027A, Exp. 04/07/2023; NB2035A, Exp. 05/22/20123; NB2038A, Exp. 06/02/2023; NB2045A, Exp. 06/25/2023; NB2053A, Exp. 07/29/2023; NB2058B, Exp. 08/16/2023; NB2064A, Exp. 09/07/2023; NB2069A, Exp. 09/25/2023; NB2071A, Exp. 10/01/2023

Distribution pattern

Nationwide in the USA

drug · product 4 of 8

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.

D-0358-2023
Recall number
D-0358-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
270,291 bottles

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

Lots: NB2018A, Exp. 02/24/2023; NB2022A, Exp. 03/08/2023; NB2028A, Exp. 04/04/2023; NB2032A, Exp. 04/24/2023; NB2036A, Exp. 05/24/2023; NB2043A, Exp. 06/17/2023; NB2046A, Exp. 06/26/2023; NB2049A, Exp. 07/21/2023; NB2052A, Exp. 07/27/2023; NB2062A, Exp. 09/13/2023; NB2068A, Exp. 09/23/2023

Distribution pattern

Nationwide in the USA

drug · product 5 of 8

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.

D-0359-2023
Recall number
D-0359-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
546,450 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

Lots: PE2025, Exp. 05/28/2023; PE2026, Exp. 06/02/2023; PE2027, Exp. 06/04/2023; PE2030, Exp. 06/29/2023; PE2031, Exp. 06/27/2023; PE2032, Exp. 07/09/2023; PE2032A, Exp. 07/09/2023; PE2033, Exp. 08/03/2023; PE2034, Exp. 08/31/2023; PE2035, Exp. 09/11/2023

Distribution pattern

Nationwide in the USA

drug · product 6 of 8

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.

D-0360-2023
Recall number
D-0360-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
31,500 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

Lots: PE2028, Exp. 06/15/2023

Distribution pattern

Nationwide in the USA

drug · product 7 of 8

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.

D-0361-2023
Recall number
D-0361-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
24,870 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

Lots: PE2029, Exp. 06/17/2023

Distribution pattern

Nationwide in the USA

drug · product 8 of 8

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.

D-0362-2023
Recall number
D-0362-2023
Initiated
February 22, 2023
Classification
Class II
Status
Terminated
Quantity
10,980 bottles

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

Lots: PS2008A, Exp. 03/07/2023

Distribution pattern

Nationwide in the USA