FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass III
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 2, 2021Historical recordClass II
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
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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