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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 10281–10300 of 17,793 recalls

Class IITerminated

Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18

Cantrell Drug Company

Lack of Sterility Assurance.

July 14, 2017 · DrugView details →

Class IITerminated

Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16

Cantrell Drug Company

Lack of Sterility Assurance.

July 14, 2017 · DrugView details →

Class IITerminated

Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03

Cantrell Drug Company

Lack of Sterility Assurance.

July 14, 2017 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18

Cantrell Drug Company

Lack of Sterility Assurance.

July 14, 2017 · DrugView details →

Class IITerminated

fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.

SCA Pharmaceuticals

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

July 14, 2017 · DrugView details →

Class IITerminated

Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13

Cantrell Drug Company

Lack of Sterility Assurance.

July 14, 2017 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18

Cantrell Drug Company

Lack of Sterility Assurance.

July 14, 2017 · DrugView details →

Class IITerminated

Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12

Cantrell Drug Company

Lack of Sterility Assurance.

July 14, 2017 · DrugView details →

Class IIITerminated

Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012

Akorn Inc

Crystallization with subpotent out of specification assay results for chlorhexidine.

July 12, 2017 · DrugView details →

Class IIITerminated

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.

Akorn Inc

Crystallization with subpotent out of specification assay results for chlorhexidine.

July 12, 2017 · DrugView details →

Class IIITerminated

Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014

Akorn Inc

Crystallization with subpotent out of specification assay results for chlorhexidine.

July 12, 2017 · DrugView details →

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