Multi-event June 2017 FDA Recall Drug by Pharmedium Services, Llc
This Multi-event Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on June 26, 2017 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; media fill failure at manufacturer. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-0997-2017 D-0987-2017 D-0992-2017 D-0988-2017 D-0985-2017 D-0989-2017 D-0994-2017 D-0986-2017 D-0995-2017 D-0996-2017 D-0991-2017 D-0993-2017 D-0990-2017
Recall Number: D-0997-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11
Batch or Lot Expiration Information
Lot# Lot: 171420030D, 8/21/2017
Recall Number: D-0987-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Batch or Lot Expiration Information
Lot# Lots: a) 171320006S Exp. 8/13/2017, 171320014D Exp. 8/13/2017,171360020D Exp. 8/15/2017, 171520063D Exp. 8/31/2017; b) 171280054D Exp. 8/7/2017, 171320002D Exp. 8/10/2017, 171370005S Exp. 8/15/2017, 171440016D Exp. 8/23/2017, 171450012D Exp. 8/24/2017, 171510059D Exp. 8/30/2017, 171560027D Exp. 9/4/2017; c) 171170014S Exp. 7/27/2017, 171210127S Exp. 7/31/2017, 171230071D Exp. 8/2/2017, 171240002D Exp. 8/3/2017, 171240004D Exp. 8/3/2017, 171240191S Exp. 8/3/2017, 171280041D Exp. 8/7/2017, 171290077D Exp. 8/8/2017, 171300076D Exp. 8/9/2017, 171310058D Exp. 8/10/2017, 171320059D Exp. 8/13/2017, 171320190S Exp. 8/13/2017, 171360062D Exp. 8/15/2017, 171360068D Exp. 8/15/2017, 171380076D Exp. 8/17/2017, 171390064D Exp. 8/20/2017, 171390065D Exp. 8/20/2017, 171500064D Exp. 8/29/2017, 171530101S Exp. 9/3/2017, 171570058D Exp. 9/5/2017; d) 171210005S Exp. 7/30/2017, 171230008D Exp. 8/2/2017, 171500072D Exp. 8/29/2017, 171560028D Exp. 9/4/2017
Recall Number: D-0992-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48
Batch or Lot Expiration Information
Lot# Lots: 171210102S Exp. 7/31/2017, 171320109S Exp. 8/13/2017, 171560012S Exp. 9/4/2017
Recall Number: D-0988-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48
Batch or Lot Expiration Information
Lot# Lot: 171320001D, 8/10/2017
Recall Number: D-0985-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
Batch or Lot Expiration Information
Lot# Lots: 171390026D Exp. 08/20/2017; 171370064D Exp. 8/16/2017; 171390027D Exp. 8/20/2017; 171420074D Exp. 8/21/2017; 171430062D Exp. 8/22/2017; 171440058D Exp. 8/23/2017; 171450001D Exp. 8/23/2017; 171450002D Exp. 8/23/2017; 171450056D Exp. 08/24/2017
Recall Number: D-0989-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
Batch or Lot Expiration Information
Lot# Lot: 171350099S, 8/14/2017
Recall Number: D-0994-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
Batch or Lot Expiration Information
Lot# Lot: 171520062D, 8/31/2017
Recall Number: D-0986-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Batch or Lot Expiration Information
Lot# Lots: a) 171280006S Exp. 8/6/2017; 171280125S Exp. 8/7/2017; 171290006S Exp. 8/7/2017; 171290028D Exp. 8/8/2017; 171360002S Exp. 8/15/2017; b) 171280011S Exp. 8/7/2017
Recall Number: D-0995-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
Batch or Lot Expiration Information
Lot# Lots: 171160002S Exp. 7/26/2017, 171560007S Exp. 9/4/2017
Recall Number: D-0996-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Batch or Lot Expiration Information
Lot# Lots: a) 171180027S Exp. 7/29/2017, 171220058D Exp. 8/1/2017, 171230013S Exp. 8/2/2017, 171360008S Exp. 8/14/2017, 171360019D Exp. 8/15/2017, 171380085D Exp. 8/17/2017, 171430069D Exp. 8/22/2017, 171560025D Exp. 9/4/2017; b) 171240007S Exp. 8/3/2017, 171280055D Exp. 8/7/2017, 171320003D Exp. 8/10/2017, 171320008S Exp. 8/13/2017, 171360005S Exp. 8/14/2017, 171370011S Exp. 8/16/2017, 171380086D Exp. 8/17/2017, 171500071D Exp. 8/29/2017
Recall Number: D-0991-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
Batch or Lot Expiration Information
Lot# Lots: 171220061D Exp. 8/1/2017, 171250023D Exp. 8/6/2017, 171430008D Exp. 8/22/2017, 171450015D Exp. 8/24/2017, 171510062D Exp. 8/30/2017
Recall Number: D-0993-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48
Batch or Lot Expiration Information
Lot# Lot: 171450017D, 8/24/2017
Recall Number: D-0990-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
06-26-2017
07-26-2017
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
Batch or Lot Expiration Information
Lot# Lots: 171220007S Exp. 7/31/2017, 171280129S Exp. 8/7/2017, 171320112S Exp. 8/13/2017, 171590010S Exp. 9/7/2017