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D-0175-2021 Class III Terminated

Recalled by US Compounding Inc — Conway, AR

FDA drug recall D-0175-2021 was initiated by US Compounding Inc on November 25, 2020 and is designated Class III. Reason for recall: Labelling: Missing label. The recall status is terminated (terminated November 5, 2021). Affected quantity: 1640 syringes.

Recall Details

Product Type: Drugs
Report Date: January 6, 2021
Initiation Date: November 25, 2020
Termination Date: November 5, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1640 syringes

Product Description

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

Reason for Recall

Labelling: Missing label.

Distribution Pattern

Nationwide

Code Information

Lot: 20202109@3 BUD: 3/20/2021

Other recalls by US Compounding Inc

D-0223-2021 Class III — Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx onl (December 16, 2020)
D-0508-2019 Class II — Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoundin (January 29, 2019)
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-0286-2016 Class II — Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional (September 12, 2015)
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-0254-2016 Class II — HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx (September 12, 2015)
D-0283-2016 Class II — Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate (September 12, 2015)
D-0237-2016 Class II — Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compoun (September 12, 2015)
D-0262-2016 Class II — Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or (September 12, 2015)