Multi-event May 2017 FDA Recall Drug by Sca Pharmaceuticals

This Multi-event Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on May 18, 2017 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-0878-2017 TERMINATED D-0874-2017 TERMINATED D-0877-2017 TERMINATED D-0879-2017 TERMINATED D-0872-2017 TERMINATED D-0873-2017 TERMINATED D-0875-2017 TERMINATED D-0876-2017 TERMINATED D-0870-2017 TERMINATED D-0871-2017 TERMINATED

Recall Number: D-0878-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
40 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32

Batch or Lot Expiration Information

Lot# 20170509@29, Use By: 08/07/17

Recall Number: D-0874-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
100 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32

Batch or Lot Expiration Information

Lot# 20170508@59, Use By: 08/06/17

Recall Number: D-0877-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
70 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32

Batch or Lot Expiration Information

Lot# 20170508@15, Use By: 06/22/17

Recall Number: D-0879-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
30 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32

Batch or Lot Expiration Information

Lot# 20170511@17, Use By: 08/09/17

Recall Number: D-0872-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
118 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32

Batch or Lot Expiration Information

Lot# 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17

Recall Number: D-0873-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
370 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32

Batch or Lot Expiration Information

Lot# 20170506@14, Use By: 08/04/17

Recall Number: D-0875-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
87 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55

Batch or Lot Expiration Information

Lot# 20170505@23, 20170505@28, Use By: 08/03/17

Recall Number: D-0876-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
240 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32

Batch or Lot Expiration Information

Lot# 20170510@12, Use By: 06-24-17

Recall Number: D-0870-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
80 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.

Batch or Lot Expiration Information

Lot# 20170508@57, Use By: 08/06/17

Recall Number: D-0871-2017

Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Initiated
05-18-2017
Reported
06-07-2017
Quantity
56 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77314
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.
SCA Pharmaceuticals
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55

Batch or Lot Expiration Information

Lot# 20170508@48, Use By: 08/06/17; 20170505@19, Use By: 08/03/17