Multi-event December 2020 FDA Recall Drug by Sca Pharmaceuticals

This Multi-event Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on December 17, 2020 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; potential for a defective syringe cap, resulting in a non-integral unit. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0188-2021 TERMINATED D-0199-2021 TERMINATED D-0217-2021 TERMINATED D-0186-2021 TERMINATED D-0193-2021 TERMINATED D-0192-2021 TERMINATED D-0206-2021 TERMINATED D-0211-2021 TERMINATED D-0204-2021 TERMINATED D-0207-2021 TERMINATED D-0202-2021 TERMINATED D-0189-2021 TERMINATED D-0201-2021 TERMINATED D-0210-2021 TERMINATED D-0216-2021 TERMINATED D-0191-2021 TERMINATED D-0214-2021 TERMINATED D-0203-2021 TERMINATED D-0198-2021 TERMINATED D-0187-2021 TERMINATED D-0215-2021 TERMINATED D-0194-2021 TERMINATED D-0196-2021 TERMINATED D-0208-2021 TERMINATED D-0213-2021 TERMINATED D-0209-2021 TERMINATED D-0197-2021 TERMINATED D-0205-2021 TERMINATED D-0200-2021 TERMINATED D-0195-2021 TERMINATED D-0190-2021 TERMINATED D-0212-2021 TERMINATED

Recall Number: D-0188-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
1,879 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509

Batch or Lot Expiration Information

Lot# 1220023041, BUD 1/20/2021; 1220023188, BUD 1/27/2021 & 1220023397, BUD 2/3/2021.

Recall Number: D-0199-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
1,880 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012

Batch or Lot Expiration Information

Lot# 1220023097, BUD 1/25/2021; 1220023134, BUD 1/25/2021 & 1220023326, BUD 2/1/2021

Recall Number: D-0217-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
9942 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009

Batch or Lot Expiration Information

Lot# 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1220023315, BUD 2/1/2021; 1220023342, BUD 2/2/2021; 1220023431, BUD 2/4/2021; 1220023471, BUD 2/3/2021; 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021.

Recall Number: D-0186-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
1,930 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006

Batch or Lot Expiration Information

Lot# 1220023001, BUD 2/5/2021; 1220023126, BUD 2/9/2021 & 1220023606, BUD 2/25/2021.

Recall Number: D-0193-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
2,834 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016

Batch or Lot Expiration Information

Lot# 1220022977, BUD 1/20/2021; 1220023122, BUD 1/25/2021; 1220023209, BUD 1/28/2021; 1220023248, BUD 1/27/2021; 1220023319, BUD 2/1/2021; 1220023496, BUD 2/8/2021 & 1220023560, BUD 2/9/2021.

Recall Number: D-0192-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
996 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122

Batch or Lot Expiration Information

Lot# 1220022911, BUD 1/18/2021; 1220023092, BUD 1/25/2021 & 1220023247, BUD 1/27/2021.

Recall Number: D-0206-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
7,940 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012

Batch or Lot Expiration Information

Lot# 1220022998, BUD 1/21/2021; 1220023115, BUD 1/25/2021; 1220023163, BUD 1/26/2021; 1220023186, BUD 1/27/2021; 1220023234, BUD 1/31/2021; 1220023393, BUD 2/3/2021; 1220023477, BUD 2/4/2021; 1220023568, BUD 2/9/2021 & 1220023625, BUD 2/11/2021.

Recall Number: D-0211-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
13,096 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205

Batch or Lot Expiration Information

Lot# a)
Lot# 1220023011, BUD 1/12/2021; 1220023027, BUD 1/19/2021; 1220023151, BUD 1/26/2021; 1220023152, BUD 1/26/2021; 1220023194, BUD 1/26/2021; 1220023228, BUD 1/28/2021; 1220023358. BUD 2/3/2021; 1220023396. BUD 2/3/2021; 1220023398, BUD 2/10/2021; 1220023569, BUD 2/9/2021 & 1220023633, BUD 2/11/2021. b)1220023031, BUD 1/19/2021; 1220023032, BUD 1/24/2021; 1220023161, BUD 1/26/2021 & 1220023224, BUD 1/28/2021.

Recall Number: D-0204-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
23,029 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012

Batch or Lot Expiration Information

Lot# 1220022957, BUD 1/20/2021; 1220022993, BUD 1/21/2021; 1220023020, BUD 1/14/2021; 1220023037, BUD 1/19/2021; 1220023038, BUD 1/20/2021; 1220023074, 1/24/2021; 1220023103, BUD 1/24/2021; 1220023160, BUD 1/26/2021; 1220023180, BUD 1/27/2021; 1220023183, BUD 1/27/2021; 1220023216, BUD 1/28/2021; 1220023267, BUD 2/1/2021; 1220023272, BUD 1/3/2021; 1220023344, BUD 2/10/2021; 1220023387, BUD 2/9/2021; 1220023475,BUD 2/4/2021; 1220023479, BUD 2/4/2021; 1220023564, BUD 2/9/2021; 1220023565, BUD 2/9/2021; 1220023587, BUD 2/10/2021 & 1220023624, BUD 2/11/2021.

Recall Number: D-0207-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
5,990 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025

Batch or Lot Expiration Information

Lot# 1220022961, BUD 1/20/2021; 1220023121, BUD 1/25/2021; 1220023207, BUD 2/12/2021; 1220023363, BUD 2/17/2021 & 1220023526, BUD 2/23/2021.

Recall Number: D-0202-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
50 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316

Batch or Lot Expiration Information

Lot# 1220023221, BUD 1/31/2021 & 1220023584, BUD 2/9/2021.

Recall Number: D-0189-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
7,257 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412

Batch or Lot Expiration Information

Lot# 1220022996, BUD 1/21/2021; 1220023017, BUD 1/20/2021; 1220023021, BUD 1/17/2021; 1220023033, BUD 1/19/2021; 1220023146, BUD 1/26/2021; 1220023189, BUD 1/27/2021 1220023242, BUD 1/25/2021; 1220023321, BUD 2/2/2021; 1220023357 BUD 2/10/2021

Recall Number: D-0201-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
751 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

Batch or Lot Expiration Information

Lot# 1220023452, BUD 2/7/2021

Recall Number: D-0210-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
14,580 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011

Batch or Lot Expiration Information

Lot# 1220022958, BUD 1/20/2021; 1220023013, BUD 1/18/2021; 1220023035, BUD 1/19/2021; 1220023036, BUD 1/21/2021; 1220023059, BUD 1/21/2021; 1220023094, BUD 1/25/2021; 1220023167, BUD 1/26/2021; 1220023208, BUD 1/27/2021; 1220023291, BUD 1/31/2021; 1220023359, BUD 2/2/2021; 1220023401, BUD 2/2/2021 & 1220023473, BUD 2/4/2021.

Recall Number: D-0216-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
3152 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022

Batch or Lot Expiration Information

Lot# 1220023003, BUD 12/22/2020; 1220023057, BUD 12/25/2020; 1220023104, BUD 12/25/2020; 1220023144, BUD 12/27/2020; 1220023168, BUD 12/27/2020; 1220023222, BUD 12/29/2020; 1220023240, BUD 12/28/2020; 1220023284, BUD 1/1/2021; 1220023456, BUD 1/8/2021; 1220023474, BUD 1/4/2021; 1220023530, BUD 1/8/2021 & 1220023542, BUD 1/9/2021.

Recall Number: D-0191-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
1,774 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422

Batch or Lot Expiration Information

Lot# 1220023275, BUD 2/15/2021; 1220023312, BUD 2/15/2021; 1220023433, 2/22/2021; 1220023515, BUD 2/24/2021 & 1220023671, BUD 3/1/2021.

Recall Number: D-0214-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
6710 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006

Batch or Lot Expiration Information

Lot# 1220023109, BUD 1/25/2021; 1220023255, BUD 1/26/2021; 1220023256. BUD 1/26/2021; 1220023257, BUD 1/28/2021; 1220023334, BUD 2/2/2021 & 1220023518, BUD 2/8/2021.

Recall Number: D-0203-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
390 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009

Batch or Lot Expiration Information

Lot# 1220023044, BUD 1/30/2021

Recall Number: D-0198-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
9,057 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028

Batch or Lot Expiration Information

Lot# 1220022969, BUD 3/1/2021; 1220023002, BUD 3/2/2021; 1220023045, BUD 3/2/2021; 1220023081, BUD 3/2/2021; 1220023130, BUD 3/6/2021; 1220023229, BUD 3/9/2021; 1220023287, BUD 3/12/2021 & 1220023335, BUD 3/22/2021.

Recall Number: D-0187-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
3,793 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509

Batch or Lot Expiration Information

Lot# 1220023305, BUD 12/17/2020; 12200223400, BUD 12/19/2020; 1220023536, BUD 12/25/2020; 1220023608, BUD 12/27/2020; 1220023811, BUD 12/26/2020 & 1220023812, BUD 12/26/2020.

Recall Number: D-0215-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
428 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022

Batch or Lot Expiration Information

Lot# 1220023220, BUD 1/31/2021; 1220023337, BUD 2/2/2021 & 1220023443, BUD 2/22/2021.

Recall Number: D-0194-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
1,614 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809

Batch or Lot Expiration Information

Lot# 1220023043, BUD 2/3/2021; 1220023141, BUD 2/9/2021; 1220023429, BUD 2/18/2021 & 1220023470, BUD 2/18/2021.

Recall Number: D-0196-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
1,056 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

Batch or Lot Expiration Information

Lot# a)
Lot# 1220022964, BUD 1/19/2021; 1220023280, BUD 2/1/2021 & 1220023623, BUD 2/10/2021. b)
Lot# 1220023347, BUD 2/17/2021.

Recall Number: D-0208-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
3,239 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812

Batch or Lot Expiration Information

Lot# 1220023028, BUD 1/19/2021; 1220023124, BUD 1/25/2021; 1220023162, BUD 1/26/2021 & 1220023210, BUD 1/28/2021.

Recall Number: D-0213-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
9416 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409

Batch or Lot Expiration Information

Lot# 1220023022, BUD 1/17/2021; 1220023023, BUD 1/17/2021; 1220023029, BUD 1/19/2021; 1220023030, BUD 1/20/2021; 1220023117, BUD 1/25/2021; 1220023145, BUD 1/26/2021 & 1220023166, BUD 1/27/2021.

Recall Number: D-0209-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
116 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016

Batch or Lot Expiration Information

Lot# 1220023412, BUD 2/2/2021; 12220023500, BUD 2/3/2021 & 1220023689 BUD 2/11/2021.

Recall Number: D-0197-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
11,075 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012

Batch or Lot Expiration Information

Lot# a)
Lot# 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b)
Lot# 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1220023315, BUD 2/1/2021; 1220023342, BUD 2/2/2021; 1220023431, BUD 2/4/2021; 1220023471, BUD 2/3/2021; 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021.

Recall Number: D-0205-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
7,890 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612

Batch or Lot Expiration Information

Lot# 1220023039, BUD 1/21/2021; 1220023080, BUD 1/24/2021; 1220023374, BUD 2/3/2021; 1220023375, BUD 2/2/2021; 1220023490, BUD 2/7/2021; 1220023554, BUD 2/8/2021 & 1220023837, BUD 2/14/2021.

Recall Number: D-0200-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
7,275 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309

Batch or Lot Expiration Information

Lot# 1220023034, BUD 1/19/2021; 1220023088, BUD 1/24/2021; 1220023112, BUD 1/25/2021; 1220023288, BUD 1/31/2021; 1220023323, BUD 2/2/2021; 1220023539, BUD 2/8/2021 & 1220023613, BUD 2/10/2021.

Recall Number: D-0195-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
3,092 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

Batch or Lot Expiration Information

Lot# a)
Lot# 1220023171, BUD 1/26/2021; 1220023282, BUD 2/1/2021; 1220023446, BUD 2/7/2021; 1220023532, BUD 2/8/2021; 1220023650, BUD 2/11/2021 & 1220023727, BUD 2/14/2021. b)
Lot# 1220023241, BUD 1/25/2021; 1220023313, BUD 2/1/2021 & 1220023442, BUD 2/7/2021.

Recall Number: D-0190-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
952 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012

Batch or Lot Expiration Information

Lot# 1220023042, BUD 1/21/2021

Recall Number: D-0212-2021

Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Initiated
12-17-2020
Reported
01-13-2021
Quantity
5067 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86990
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.
Product was distributed to hospitals nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809

Batch or Lot Expiration Information

Lot# 1220023019, BUD 1/17/2021; 1220023025, BUD 1/18/2021; 1220023026, BUD 1/24/2021 & 1220023264, BUD 2/1/2021.