Multi-event June 2017 FDA Recall Drug by Sca Pharmaceuticals
This Multi-event Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on June 21, 2017 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed in LA, PA, NY, WI and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0976-2017
Lack of sterility assurance
06-21-2017
07-19-2017
221 bags
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.
SCA Pharmaceuticals
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
LA, PA, NY, WI
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
Batch or Lot Expiration Information
Lot# : 20170509@2, Exp 6/23/2017; 20170524@22, Exp 7/8/2017; 20170602@10, Exp 7/17/2017; 20170609@27, Exp 7/24/2017
Recall Number: D-0977-2017
Lack of sterility assurance
06-21-2017
07-19-2017
660 bags
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.
SCA Pharmaceuticals
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
LA, PA, NY, WI
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
Batch or Lot Expiration Information
Lot# : 20170509@6, Exp 6/23/2017; 20170519@35, Exp 7/3/2017; 20170523@22, Exp 7/7/2017; 20170525@9, Exp 7/9/2017; 20170605@49, Exp 7/20/2017; 20170605@9, Exp 7/20/2017
Recall Number: D-0978-2017
Lack of sterility assurance
06-21-2017
07-19-2017
20 bags
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.
SCA Pharmaceuticals
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
LA, PA, NY, WI
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32
Batch or Lot Expiration Information
Lot# : 20170602@29, Exp 7/17/2017
Recall Number: D-0979-2017
Lack of sterility assurance
06-21-2017
07-19-2017
20 bags
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.
SCA Pharmaceuticals
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
LA, PA, NY, WI
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40
Batch or Lot Expiration Information
Lot# : 20170511@58, Exp 6/25/2017
