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D-0508-2019 Class II Terminated

Recalled by US Compounding Inc — Conway, AR

FDA drug recall D-0508-2019 was initiated by US Compounding Inc on January 29, 2019 and is designated Class II. Reason for recall: Lack of assurance of sterility. The recall status is terminated (terminated January 24, 2020). Affected quantity: 1686 syringes.

Recall Details

Product Type: Drugs
Report Date: February 27, 2019
Initiation Date: January 29, 2019
Termination Date: January 24, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1686 syringes

Product Description

Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407

Reason for Recall

Lack of assurance of sterility.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot: 20181812@2 BUD: 06/16/2019

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D-0223-2021 Class III — Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx onl (December 16, 2020)
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D-0482-2019 Class II — LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL (January 24, 2019)
D-0219-2017 Class I — Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 m (July 25, 2016)
D-0245-2016 Class II — Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For top (September 12, 2015)
D-0276-2016 Class II — Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Co (September 12, 2015)
D-0273-2016 Class II — Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injecti (September 12, 2015)
D-0285-2016 Class II — Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional I (September 12, 2015)
D-0286-2016 Class II — Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional (September 12, 2015)
D-0283-2016 Class II — Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate (September 12, 2015)