Multi-event November 2021 FDA Recall Drug by Sterrx, Llc

This Multi-event Class II drug recall was voluntarily initiated by Sterrx, Llc on November 12, 2021 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0305-2022 TERMINATED D-0308-2022 TERMINATED D-0301-2022 TERMINATED D-0314-2022 TERMINATED D-0318-2022 TERMINATED D-0321-2022 TERMINATED D-0323-2022 TERMINATED D-0317-2022 TERMINATED D-0313-2022 TERMINATED D-0303-2022 TERMINATED D-0320-2022 TERMINATED D-0300-2022 TERMINATED D-0302-2022 TERMINATED D-0312-2022 TERMINATED D-0325-2022 TERMINATED D-0315-2022 TERMINATED D-0324-2022 TERMINATED D-0309-2022 TERMINATED D-0316-2022 TERMINATED D-0319-2022 TERMINATED D-0307-2022 TERMINATED D-0306-2022 TERMINATED D-0304-2022 TERMINATED D-0322-2022 TERMINATED D-0310-2022 TERMINATED D-0311-2022 TERMINATED

Recall Number: D-0305-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
18,948 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.

Batch or Lot Expiration Information

Lot# S21086/BQW 14-Dec-21 S21149/BTH 23-Jan-22 S21159/BTQ 30-Jan-22 S21265/BXI 3-Apr-22 S21305/BYU 24-Apr-22 S21311/BZA 26-Apr-22

Recall Number: D-0308-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
26,928 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.

Batch or Lot Expiration Information

Lot# S21254/BWZ 22-Nov-21 S21263/BXG 30-Nov-21 S21333/BZT 11-Jan-22 S21398/CCG 19-Feb-22

Recall Number: D-0301-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
880 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.

Batch or Lot Expiration Information

Lot# S21317/BZE

Recall Number: D-0314-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
1428 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.

Batch or Lot Expiration Information

Lot# S21409/CCR

Recall Number: D-0318-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
880 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.

Batch or Lot Expiration Information

Lot# S21292/BYI

Recall Number: D-0321-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
74,508 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.

Batch or Lot Expiration Information

Lot# S21162/BTT 13-Nov-21 S21163/BTU 13-Nov-21 S21167/BTY 19-Nov-21 S21174/BUF 20-Nov-21 S21175/BUG 21-Nov-21 S21217/BVS 12-Dec-21 S21218/BVT 12-Dec-21 S21219/BVU 16-Dec-21 S21241/BWL 24-Dec-21 S21281/BXY 20-Jan-22 S21282/BXZ 23-Jan-22 S21283/BYA 22-Jan-22 S21297/BYN 28-Jan-22 S21340/CAA 27-Feb-22 S21342/CAC 5-Mar-22 S21352/CAL 6-Mar-22 S21359/CAS 11-Mar-22 S21362/CAV 12-Mar-22 S21368/CBB 13-Mar-22 S21369/CBC 19-Mar-22 S21415/CCX 7-Apr-22 S21419/CDB 7-Apr-22 S21434/CDP 16-Apr-22

Recall Number: D-0323-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
20640 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.

Batch or Lot Expiration Information

Lot# S21087/BQX 16-Dec-21 S21151/BTJ 24-Jan-22 S21186/BUQ 14-Feb-22 S21189/BUS 16-Feb-22 S21266/BXJ 3-Apr-22 S21307/BYW 24-Apr-22 S21313/BZC 27-Apr-22

Recall Number: D-0317-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
5000 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.

Batch or Lot Expiration Information

Lot# S21353/CAM 26-Mar-22 S21358/CAR 30-Mar-22 S21364/CAX 6-Apr-22

Recall Number: D-0313-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
40 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.

Batch or Lot Expiration Information

Lot# S21293/BYJ

Recall Number: D-0303-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
9360 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.

Batch or Lot Expiration Information

Lot# S21192/BUV 18-Apr-22 S21205/BVH 23-Apr-22 S21402/CCK 21-Aug-22

Recall Number: D-0320-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
121,584 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.

Batch or Lot Expiration Information

Lot# S20415/BKY 12-Nov-21 S20418/BLB 13-Nov-21 S20452/BMI 5-Dec-21 S20463/BMT 9-Dec-21 S20464/BMU 18-Dec-21 S20478/BNF 23-Dec-21 S21021/BOI 6-Jan-22 S21033/BOU 20-Jan-22 S21047/BPH 21-Jan-22 S21059/BPU 28-Jan-22 S21094/BRE 18-Feb-22 S21117/BSB 3-Mar-22 S21118/BSC 10-Mar-22 S21138/BSW 17-Mar-22 S21227/BWA 7-May-22 S21239/BWK 12-May-22 S21279/BXW 5-Jun-22 S21295/BYL 16-Jun-22 S21298/BYO 18-Jun-22 S21339/BZZ 16-Jul-22 S21346/CAF 21-Jul-22 S21355/CAO 28-Jul-22 S21370/CBD 4-Aug-22 S21372/CBF 7-Aug-22 S21438/CDS 4-Sep-22

Recall Number: D-0300-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
15660 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.

Batch or Lot Expiration Information

Lot# Lots S21131/BSP, 10-Nov-21 S21132/BSQ, 11-Nov-21 S21139/BSX, 18-Nov-21 S21150/BTI, 24-Nov-21 S21158/BTP, 1-Dec-21 S21160/BTR, 2-Dec-21 & S21170/BUB, 9-Dec-21.

Recall Number: D-0302-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
24300 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.

Batch or Lot Expiration Information

Lot# Lots S21164/BTV, 3-Dec-21; S21191/BUU, 18-DEC-21; S21197/BUZ, 31-Dec-21; S21220/BVV, 13-Jan-22; S21271/BX0, 27-Jan-22; S21272/BXP, 28-Jan-22; S21299/BYP, 18-Fev-22; S21300/BYQ, 19-Feb-22

Recall Number: D-0312-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
36360 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.

Batch or Lot Expiration Information

Lot# S21065/BQA 12-Nov-21 S21066/BQB 19-Nov-21 S21142/BTA 19-Nov-21 S21143/BTB 20-Nov-21 S21146/BTE 21-Nov-21 S21147/BTF 25-Nov-21 S21148/BTG 25-Nov-21 S21153/BTL 26-Nov-21 S21154/BTM 27-Nov-21 S21171/BUC 10-Dec-21 S21172/BUD 11-Dec-21 S21173/BUE 15-Dec-21 S21190/BUT 16-Dec-21 S21201/BVD 22-Dec-21 S21202/BVE 24-Dec-21 S21203/BVF 29-Dec-21 S21204/BVG 19-Jan-22 S21258/BXD 20-Jan-22 S21275/BXS 30-Jan-22 S21276/BXT 2-Feb-22 S21277/BXU 3-Feb-22 S21278/BXV 3-Feb-22 S21284/BYB 4-Feb-22 S21285/BYC 5-Feb-22 S21286/BYD 11-Feb-22 S21287/BYE 12-Feb-22 S21290/BYH 16-Feb-22 S21304/BYT 23-Feb-22 S21306/BYV 24-Feb-22 S21308/BYX 25-Feb-22 S21310/BYZ 26-Feb-22 S21379/CBM 14-Apr-22 S21382/CBP 14-Apr-22 S21385/CBS 15-Apr-22

Recall Number: D-0325-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
2886 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03

Batch or Lot Expiration Information

Lot# S20459/BMP 17-Nov-21 S20472/BMZ 18-Nov-21 S20473/BNA 18-Nov-21

Recall Number: D-0315-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
8946 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.

Batch or Lot Expiration Information

Lot# S21200/BVC 15-Nov-21 S21296/BYM 19-Dec-21 S21320/BZG 4-Jan-22 S21164/BTV 3-Dec-21 S21191/BUU 18-Dec-21 S21197/BUZ 31-Dec-21 S21220/BVV 13-Jan-22 S21271/BXO 27-Jan-22 S21272/BXP 28-Jan-22 S21299/BYP 18-Feb-22 S21300/BYQ 19-Feb-22

Recall Number: D-0324-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
23,136 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.

Batch or Lot Expiration Information

Lot# S21088/BQY 19-Dec-21 S21152/BTK 25-Jan-22 S21161/BTS 31-Jan-22 S21289/BYG 4-Apr-22 S21309/BYY 25-Apr-22 S21314/BZD 2-May-22 S21378/CBL 12-Jun-22

Recall Number: D-0309-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
7548 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.

Batch or Lot Expiration Information

Lot# S21255/BXA 22-Jan-22 S21264/BXH 29-Jan-22 S21328/BZO 10-Mar-22

Recall Number: D-0316-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
10660 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.

Batch or Lot Expiration Information

Lot# S21349/CAI 23-Mar-22 S21356/CAP 1-Apr-22 S21361/CAU 2-Apr-22

Recall Number: D-0319-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
1044 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.

Batch or Lot Expiration Information

Lot# S21194/CDW

Recall Number: D-0307-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
3540 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.

Batch or Lot Expiration Information

Lot# S21367/CBA 18-Nov-21 S21403/CCL 9-Dec-21

Recall Number: D-0306-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
127,260 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

Batch or Lot Expiration Information

Lot# S20483/BNJ 23-Nov-21 S20484/BNK 24-Nov-21 S20485/BNL 25-Nov-21 S21008/BNV 3-Dec-21 S21010/BNX 9-Dec-21 S21025/BOM 10-Dec-21 S21026/BON 15-Dec-21 S21027/BOO 16-Dec-21 S21035/BOW 17-Dec-21 S21045/BPF 18-Dec-21 S21046/BPG 21-Dec-21 S21050/BPK 22-Dec-21 S21054/BPO 24-Dec-21 S21055/BPQ 25-Dec-21 S21061/BPW 28-Dec-21 S21062/BPX 29-Dec-21 S21063/BPY 30-Dec-21 S21064/BPZ 31-Dec-21 S21069/BQE 31-Dec-21 S21073/BQI 4-Jan-22 S21074/BQJ 5-Jan-22 S21076/BQL 6-Jan-22 S21077/BQM 7-Jan-22 S21081/BQQ 20-Jan-22 S21083/BQS 22-Jan-22 S21084/BQT 25-Jan-22 S21110/BRU 26-Jan-22 S21111/BRV 27-Jan-22 S21112/BRW 27-Jan-22 S21113/BRX 28-Jan-22 S21114/BRY 1-Feb-22 S21115/BRZ 1-Feb-22 S21123/BSH 2-Feb-22 S21124/BSI 3-Feb-22 S21126/BSK 3-Feb-22 S21127/BSL 4-Feb-22 S21128/BSM 4-Feb-22 S21129/BSN 5-Feb-22 S21168/BTZ 10-Mar-22 S21169/BUA 11-Mar-22 S21176/BUH 15-Mar-22 S21181/BUL 17-Mar-22 S21182/BUM 17-Mar-22 S21270/BXN 26-May-22 S21274/BXR 26-May-22 S21321/BZH 1-Jun-22 S21322/BZI 2-Jun-22 S21323/BZJ 3-Jun-22 S21324/BZK 3-Jun-22 S21325/BZL 7-Jun-22 S21329/BZP 8-Jun-22 S21336/BZW 14-Jun-22 S21337/BZX 15-Jun-22 S21338/BZY 16-Jun-22 S21341/CAB 17-Jun-22 S21343/CAD 18-Jun-22 S21348/CAH 23-Jun-22 S21350/CAJ 24-Jun-22 S21351/CAK 28-Jun-22 S21357/CAQ 1-Jul-22 S21360/CAT 2-Jul-22 S21363/CAW 5-Jul-22 S21366/CAZ 7-Jul-22 S21374/CBH 8-Jul-22 S21376/CBJ 8-Jul-22 S21377/CBK 12-Jul-22 S21381/CBO 13-Jul-22 S21384/CBR 13-Jul-22 S21387/CBU 13-Jul-22 S21390/CBX 14-Jul-22 S21392/CBZ 14-Jul-22 S21393/CCA 15-Jul-22 S21396/CCD 15-Jul-22 S21397/CCF 19-Jul-22 S21399/CCH 19-Jul-22 S21401/CCJ 20-Jul-22 S21404/CCM 21-Jul-22

Recall Number: D-0304-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
2779 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.

Batch or Lot Expiration Information

Lot# S21257/BXC

Recall Number: D-0322-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
36,576 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.

Batch or Lot Expiration Information

Lot# S21082/BQV 13-Nov-21 S21102/BRM 28-Nov-21 S21135/BST 14-Dec-21 S21166/BTX 7-Jan-22 S21178/BUJ 28-Jan-22 S21226/BVZ 5-Feb-22 S21237/BWI 7-Feb-22 S21242/BWM 13-Feb-22 S21280/BXX 11-Mar-22 S21302/BYS 21-Mar-22 S21345/CAE 23-Apr-22 S21424/CDG 28-May-22

Recall Number: D-0310-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
5832 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.

Batch or Lot Expiration Information

Lot# S21255/BXA 22-Jan-22 S21264/BXH 29-Jan-22 S21328/BZO 10-Mar-22

Recall Number: D-0311-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-12-2021
Reported
01-05-2022
Quantity
684 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89059
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SterRx, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.

Batch or Lot Expiration Information

Lot# S21335/BZV