Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 62 of 251
SCA Pharmaceuticals
Class II Terminated
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...
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0196-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0189-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0204-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0216-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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...
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0195-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0197-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0193-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0188-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class III Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0201-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0190-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0206-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0210-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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, bar...
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0187-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0205-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0194-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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 La...
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0211-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0208-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0186-2021 January 13, 2021 Windsor, CT
Merck Sharp & Dohme
Class II Terminated
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01
Reason: Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii ...
D-0176-2021 January 13, 2021 Rahway, NJ
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0217-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0207-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0213-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0199-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
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
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0209-2021 January 13, 2021 Windsor, CT
Imprimis NJOF, LLC
Class II Terminated
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
Reason: Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
D-0177-2021 January 6, 2021 Ledgewood, NJ