Home / Recalls / US Compounding Inc / D-0274-2016

D-0274-2016 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
862 bottles

Product Description

Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.

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 Code: 20151803@4 BUD: 9/14/2015, 20152005@19 BUD: 11/16/2015, 20152307@15 BUD: 1/19/2016, 20153003@4 BUD: 9/26/2015

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-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-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-0293-2016 Class II — Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmi (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)