Multi-event March 2020 FDA Recall Drug by Pharmedium Services, Llc

This Multi-event Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on March 16, 2020 for the product Drug. The FDA reported the reason for recall as firm is recalling 46 lots of various products because of a lack of sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1083-2020 TERMINATED D-1089-2020 TERMINATED D-1084-2020 TERMINATED D-1088-2020 TERMINATED D-1092-2020 TERMINATED D-1085-2020 TERMINATED D-1091-2020 TERMINATED D-1086-2020 TERMINATED D-1081-2020 TERMINATED D-1082-2020 TERMINATED D-1090-2020 TERMINATED D-1093-2020 TERMINATED D-1087-2020 TERMINATED

Recall Number: D-1083-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
4625 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10

Batch or Lot Expiration Information

Lot# 193510017D 3/17/2020 193530001D 3/19/2020 193540002D 3/22/2020

Recall Number: D-1089-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
290 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44

Batch or Lot Expiration Information

Lot# 193510008D 3/17/2020 193580004D 3/25/020

Recall Number: D-1084-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
1840 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44

Batch or Lot Expiration Information

Lot# 193510022D 3/17/2020 193510023D 3/17/2020 193580012D 3/25/2020 193600013D 3/26/2020 193640016D 3/30/2020 193530020D 3/19/2020 193540023D 3/22/2020 193540026D 3/22/2020

Recall Number: D-1088-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
375 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09

Batch or Lot Expiration Information

Lot# 193500012D, Exp 3/16/2020

Recall Number: D-1092-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
75 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33

Batch or Lot Expiration Information

Lot# 193530007D, Exp 3/19/2020

Recall Number: D-1085-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
210 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

Batch or Lot Expiration Information

Lot# 193610002D, Exp 3/29/2020

Recall Number: D-1091-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
900 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09

Batch or Lot Expiration Information

Lot# 193520006D 3/18/2020 193530009D 3/19/2020

Recall Number: D-1086-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
2475 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04

Batch or Lot Expiration Information

Lot# 193500014D 3/16/2020 193510018D 3/17/2020

Recall Number: D-1081-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
1075 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12

Batch or Lot Expiration Information

Lot# 193500004D 3/16/2020 193510006D 3/17/2020 193530011D 3/19/2020 193570003D 3/23/2020

Recall Number: D-1082-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
80 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01

Batch or Lot Expiration Information

Lot# 193540006D, Exp 3/22/2020

Recall Number: D-1090-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
1500 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02

Batch or Lot Expiration Information

Lot# 193510031D, Exp 3/17/2020

Recall Number: D-1093-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
1350 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28

Batch or Lot Expiration Information

Lot# 193520008D, Exp 3/18/2020 193540005D, Exp 3/22/2020

Recall Number: D-1087-2020

Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Initiated
03-16-2020
Reported
04-15-2020
Quantity
2250 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85212
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.
PharMEDium Services, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2025
Product Description About Product Description
Full technical description of the product.
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05

Batch or Lot Expiration Information

Lot# 193500019D 3/16/2020 193510014D 3/17/2020 193520009D 3/18/2020