Multi-event July 2020 FDA Recall Drug by Sca Pharmaceuticals

This Multi-event Class I drug recall was voluntarily initiated by Sca Pharmaceuticals on July 29, 2020 for the product Drug. The FDA reported the reason for recall as cross contamination with other product(s). The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1553-2020 TERMINATED D-1552-2020 TERMINATED D-1550-2020 TERMINATED D-1551-2020 TERMINATED

Recall Number: D-1553-2020

Reason for Recall
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Initiated
07-29-2020
Reported
09-02-2020
Quantity
362 Containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86193
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 within the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-21-2021
Product Description About Product Description
Full technical description of the product.
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.

Batch or Lot Expiration Information

Lot# : 1220019457, Exp 08/24/2020

Recall Number: D-1552-2020

Reason for Recall
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Initiated
07-29-2020
Reported
09-02-2020
Quantity
1,527 Containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86193
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 within the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-21-2021
Product Description About Product Description
Full technical description of the product.
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.

Batch or Lot Expiration Information

Lot# : 1220019243, Exp 08/20/2020; 1220019439,1220019279, 1220019392, Exp 08/24/2020; 1220019488, Exp 08/26/2020.

Recall Number: D-1550-2020

Reason for Recall
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Initiated
07-29-2020
Reported
09-02-2020
Quantity
1,097 Containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86193
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 within the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-21-2021
Product Description About Product Description
Full technical description of the product.
Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.

Batch or Lot Expiration Information

Lot# : 1220019269, 1220019278, Exp 08/21/2020; 1220019386, Exp 08/25/2020.

Recall Number: D-1551-2020

Reason for Recall
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Initiated
07-29-2020
Reported
09-02-2020
Quantity
366 Containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86193
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 within the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-21-2021
Product Description About Product Description
Full technical description of the product.
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.

Batch or Lot Expiration Information

Lot# : 1220019289, Exp 08/21/2020.