Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC ...
Reason: Lack of Assurance of Sterility
D-0933-2023July 26, 2023Plattsburgh, NY
SterRx, LLC
Class IITerminated
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ND...
Reason: Lack of Assurance of Sterility
D-0930-2023July 26, 2023Plattsburgh, NY
SterRx, LLC
Class IITerminated
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Reason: Lack of Assurance of Sterility
D-0934-2023July 26, 2023Plattsburgh, NY
SterRx, LLC
Class IITerminated
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 703...
Reason: Lack of Assurance of Sterility
D-0932-2023July 26, 2023Plattsburgh, NY
SterRx, LLC
Class IITerminated
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 703...
Reason: Lack of Assurance of Sterility
D-0931-2023July 26, 2023Plattsburgh, NY
B. Braun Medical Inc.
Class IITerminated
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Reason: Lack of assurance of sterility: bags have the potential to leak.
D-0916-2023July 19, 2023Daytona Beach, FL
Global Pharma Healthcare Private Limited
Class IOngoing
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 1...
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
D-0919-2023July 19, 2023Chennai, N/A
Golden State Medical Supply Inc.
Class IITerminated
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottl...
Reason: Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
D-0867-2023June 14, 2023Camarillo, CA
Fresenius Medical Care Holdings, Inc.
Class IITerminated
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Reason: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
D-0777-2023June 7, 2023Waltham, MA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdri...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0694-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 7128...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0727-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0741-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 712...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0738-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allento...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0665-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0747-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0650-2023May 31, 2023Allentown, PA
Sagent Pharmaceuticals Inc
Class IIOngoing
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Reason: Lack of Assurance of Sterility
D-0763-2023May 31, 2023Schaumburg, IL
Central Admixture Pharmacy Services, Inc.
Class IITerminated
NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0743-2023May 31, 2023Allentown, PA
Sagent Pharmaceuticals Inc
Class IIOngoing
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Reason: Lack of Assurance of Sterility
D-0762-2023May 31, 2023Schaumburg, IL
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snow...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0696-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1.
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0728-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-607...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0720-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 65...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
D-0669-2023May 31, 2023Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-021...
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.