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D-1061-2017 Class II Terminated

Recalled by Cantrell Drug Company — Little Rock, AR

FDA drug recall D-1061-2017 was initiated by Cantrell Drug Company on July 14, 2017 and is designated Class II. Reason for recall: Lack of Sterility Assurance. The recall status is terminated (terminated September 16, 2020). Affected quantity: 24638 syringes.

Recall Details

Product Type: Drugs
Report Date: August 16, 2017
Initiation Date: July 14, 2017
Termination Date: September 16, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24638 syringes

Product Description

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

Reason for Recall

Lack of Sterility Assurance.

Distribution Pattern

Nationwide within the US

Code Information

Lot #: 9906, 9915 BUD: 7/28/2017; 9950, 9984, 10001,10010, BUD: 8/4/2017; 10064, BUD: 8/17/2017; 10341, 10452 BUD: 9/23/2017,

Other recalls by Cantrell Drug Company

D-1078-2017 Class II — Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Do (July 14, 2017)
D-1075-2017 Class II — Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose S (July 14, 2017)
D-1064-2017 Class II — Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Do (July 14, 2017)
D-1076-2017 Class II — Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syring (July 14, 2017)
D-1065-2017 Class II — Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syring (July 14, 2017)
D-1072-2017 Class II — Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per (July 14, 2017)
D-1071-2017 Class II — Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per (July 14, 2017)
D-1063-2017 Class II — Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Sy (July 14, 2017)
D-1079-2017 Class II — Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Sy (July 14, 2017)
D-1068-2017 Class II — Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Singl (July 14, 2017)