Exact FDA event identifier

Event 90211

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

Event summary

Timeline bucket: May 18, 2022
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

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

20 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 20

8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50

D-0950-2022

Recall number: D-0950-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 13612 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: SB2001A, Exp. 1/2/2023; SB2005B, SB2005C, Exp. 3/8/2023; SB2006A, SB2006B, SB2006C, Exp. 3/16/2023

Distribution pattern

Nationwide in the USA

drug · product 2 of 20

Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10

D-0951-2022

Recall number: D-0951-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 30180 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: CG1003A, Exp. 12/3/2022; CG2001A, Exp. 2/10/2023

Distribution pattern

Nationwide in the USA

drug · product 3 of 20

EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10

D-0952-2022

Recall number: D-0952-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 35850 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: EN2005A, Exp. 7/25/2022; EN2009A, Exp. 8/20/2022; EN2010A, Exp. 9/13/2022

Distribution pattern

Nationwide in the USA

drug · product 4 of 20

Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10

D-0953-2022

Recall number: D-0953-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 134415 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: EN1047A, Exp. 6/7/2022; EN2002A, Exp. 7/7/2022; EN2006A, Exp. 7/19/2022; EN2011A, Exp. 9/1/2022

Distribution pattern

Nationwide in the USA

drug · product 5 of 20

Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21

D-0954-2022

Recall number: D-0954-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 3532 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: FN1088A, Exp. 6/21/2022; FN1089A, Exp. 6/26/2022

Distribution pattern

Nationwide in the USA

drug · product 6 of 20

Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05

D-0955-2022

Recall number: D-0955-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 32,550 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: GL2002B Exp. 8/13/2022

Distribution pattern

Nationwide in the USA

drug · product 7 of 20

Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03

D-0956-2022

Recall number: D-0956-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 6150 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: GL2002A, Exp. 8/13/2022

Distribution pattern

Nationwide in the USA

drug · product 8 of 20

Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50

D-0957-2022

Recall number: D-0957-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 2795 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: HN2005A, Exp. 9/17/2022

Distribution pattern

Nationwide in the USA

drug · product 9 of 20

Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30

D-0958-2022

Recall number: D-0958-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 6210 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: HH2008A, Exp. 9/5/2022

Distribution pattern

Nationwide in the USA

drug · product 10 of 20

Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33

D-0959-2022

Recall number: D-0959-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 30,290 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: KH2008A, Exp. 8/8/2022

Distribution pattern

Nationwide in the USA

drug · product 11 of 20

Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55

D-0960-2022

Recall number: D-0960-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 107530 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: KH1086A, Exp. 6/24/2022; KH2002B, Exp. 7/5/2022; KH2008B, Exp. 8/8/2022; KH2012A, Exp. 8/23/2022

Distribution pattern

Nationwide in the USA

drug · product 12 of 20

Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04

D-0961-2022

Recall number: D-0961-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 115640 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: LB1020A, LB1022A Exp. 5/21/2022; LB2003A, Exp. 8/5/2022; LB2007A, Exp. 9/20/2022

Distribution pattern

Nationwide in the USA

drug · product 13 of 20

Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05

D-0962-2022

Recall number: D-0962-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 65590 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: LI2001A, Exp. 6/8/2022

Distribution pattern

Nationwide in the USA

drug · product 14 of 20

Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05

D-0963-2022

Recall number: D-0963-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 64450 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: NE2001A, Exp. 6/30/2022; NE2009B, Exp. 8/27/2022

Distribution pattern

Nationwide in the USA

drug · product 15 of 20

Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50

D-0964-2022

Recall number: D-0964-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 3587 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: OX2008C, Exp. 5/27/2022; OX2010C, Exp. 6/17/2022; OX2011C, OX2011D, Exp. 6/24/2022

Distribution pattern

Nationwide in the USA

drug · product 16 of 20

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10

D-0965-2022

Recall number: D-0965-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 57810 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: PE1108A, Exp. 5/27/2022; PE2006A, Exp. 8/3/2022; PE2010A, Exp. 8/12/2022

Distribution pattern

Nationwide in the USA

drug · product 17 of 20

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10

D-0966-2022

Recall number: D-0966-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 76860 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: PE1107A, Exp. 5/22/2022; PE1123A, Exp. 6/21/2022; PE2007A, Exp. 8/4/2022; PE2012A, Exp. 8/28/2022

Distribution pattern

Nationwide in the USA

drug · product 18 of 20

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10

D-0967-2022

Recall number: D-0967-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 585660 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: PE1115B, PE1115C, Exp. 5/31/2022; PE1122A, Exp. 6/19/2022; PE2004B, PE2004C, Exp. 7/11/2022; PE2011A, PE2011C, Exp. 8/22/2022; PE2015A, PE2015B, PE2015C, Exp. 9/5/2022; PE2016A, PE2016B, PE2016C, Exp. 9/13/2022

Distribution pattern

Nationwide in the USA

drug · product 19 of 20

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05

D-0968-2022

Recall number: D-0968-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 604080 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: RC1050A, Exp. 5/30/2022; RC1051B, Exp. 6/6/2022; RC1053A, Exp. 6/27/2022; RC2001A, Exp. 7/19/2022; RC2002A, Exp. 8/13/2022; RC2003A, Exp. 8/28/2022; RC2004A, Exp. 9/8/2022

Distribution pattern

Nationwide in the USA

drug · product 20 of 20

Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05

D-0969-2022

Recall number: D-0969-2022
Initiated: May 18, 2022
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 181560 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

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: SU2004A, Exp. 5/18/2022; SU2007A, Exp. 6/2/2022

Distribution pattern

Nationwide in the USA