Cantrell Drug Company: Subpotent Drug; Stability Data Does Not Support Expiry

Agency Publication Date: July 6, 2016

Affected Products

Product: fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450

Lot: 6234, exp 9/20/15

Lot Numbers:

6234

Product: Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453

a) Lots: 149690, exp 9/14/15 and 151665, exp 11/5/15 and b) Lots: 149198, exp 9/3/15; 151454, exp 9/14/15; 151668, exp 11/5/15 and 151962, exp 11/11/15

Product: fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131

Lot: 150125, 12/19/15

Lot Numbers:

150125

Product: fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301

Lot: 151142, exp 10/22/15

Lot Numbers:

151142

Product: fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR

a) Lots: 148292, exp 11/9/15 and 150610, exp 1/6/16 and b) Lots: 6208, exp 9/16/15 and 6851, exp 1/19/16

Product: fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491

Lot: 150370, exp 1/2/16

Lot Numbers:

150370

Product: fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165

Lot: 6324, exp 10/11/15

Lot Numbers:

6324

Product: HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212

Lot: 150090, exp 12/24/15

Lot Numbers:

150090

Product: HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163

Lot: 6146, exp 9/5/15

Lot Numbers:

6146

Product: LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033

Lot: 150947, exp 9/5/15; 151087, exp 9/21/15

Lot Numbers:

150947

Product: Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455

Lot: 6218, exp 9/17/15; 6877, exp 1/24/16

Lot Numbers:

6218

Product: MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721

Lot: 149167, exp 9/2/15

Lot Numbers:

149167

Product: MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161

Lot: 6178, exp, 9/12/15; 6529, exp 11/22/15

Lot Numbers:

6178

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72028

Status: Resolved

Manufacturer: Cantrell Drug Company

Manufactured In: United States

Units Affected: 13 products (884 syringes; a) 450 syringes and b) 1250 syringes; 42 syringes; 235 syringes; a) 564 syringes and b) 1146 syringes; 148 syringes; 1652 syringes; 352 syringes; 4170 syringes; 450 syringes; 3853 syringes; 212 syringes; 1570 syringes)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Product: fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450

Lot: 6234, exp 9/20/15

Lot Numbers:

6234

a) Lots: 149690, exp 9/14/15 and 151665, exp 11/5/15 and b) Lots: 149198, exp 9/3/15; 151454, exp 9/14/15; 151668, exp 11/5/15 and 151962, exp 11/11/15

Product: fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131

Lot: 150125, 12/19/15

Lot Numbers:

150125

Product: fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301

Lot: 151142, exp 10/22/15

Lot Numbers:

151142

a) Lots: 148292, exp 11/9/15 and 150610, exp 1/6/16 and b) Lots: 6208, exp 9/16/15 and 6851, exp 1/19/16

Product: fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491

Lot: 150370, exp 1/2/16

Lot Numbers:

150370

Product: fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165

Lot: 6324, exp 10/11/15

Lot Numbers:

6324

Product: HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212

Lot: 150090, exp 12/24/15

Lot Numbers:

150090

Product: HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163

Lot: 6146, exp 9/5/15

Lot Numbers:

6146

Product: LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033

Lot: 150947, exp 9/5/15; 151087, exp 9/21/15

Lot Numbers:

150947

Product: Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455

Lot: 6218, exp 9/17/15; 6877, exp 1/24/16

Lot Numbers:

6218

Product: MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721

Lot: 149167, exp 9/2/15

Lot Numbers:

149167

Product: MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161

Lot: 6178, exp, 9/12/15; 6529, exp 11/22/15

Lot Numbers:

6178

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72028

Status: Resolved

Manufacturer: Cantrell Drug Company

Manufactured In: United States