Home / Recalls / US Compounding Inc / D-0257-2016

D-0257-2016 Class II Terminated

Recalled by US Compounding Inc — Conway, AR

Recall Details

Product Type
Drugs
Report Date
November 25, 2015
Initiation Date
September 12, 2015
Termination Date
March 30, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
105 syringes

Product Description

Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

Reason for Recall

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Distribution Pattern

Nationwide

Code Information

Lot Numbers: 20151806@30 BUD: 11/7/2015, 20152306@38 BUD: 11/7/2015, 20151806@29 BUD: 11/7/2015, 20151903@30 BUD: 9/15/2015

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-0175-2021 Class III — Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/ (November 25, 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-0293-2016 Class II — Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmi (September 12, 2015)
  • D-0283-2016 Class II — Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate (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-0260-2016 Class II — L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx (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)