Home / Recalls / US Compounding Inc / D-0254-2016

D-0254-2016 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
7,852 vials

Product Description

HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99

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: 20150806@22 BUD: 12/5/2015; 20150106@12 BUD: 11/28/2015; 20150106@20 BUD: 11/28/2015; 20150604@2 BUD: 10/3/2015; 20150604@2 BUD: 10/3/2015; 20150607@9 BUD: 1/2/2016; 20150806@22 BUD: 12/5/2015; 20151304@13 BUD: 10/10/2015; 20151506@22 BUD: 12/12/2015; 20152007@4 BUD: 1/16/2016; 20152206@20 BUD: 12/19/2015; 20152303@11 BUD: 9/19/2015; 20152303@2 BUD: 9/19/2015; 20152704@2 BUD: 10/24/2015; 20152707@3 BUD: 1/23/2016; 20152707@9 BUD: 1/23/2016; 20152303@11 BUD: 9/19/2015

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-0262-2016 Class II — Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or (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-0243-2016 Class II — Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded b (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)