Home / Recalls / US Compounding Inc / D-0237-2016

D-0237-2016 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
82 vials

Product Description

Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.

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: 20150408@10 BUD: 1/27/2015; 20151407@11 BUD: 1/10/2015; 20151604@8 9/16/2015; 20152703@2 9/16/2015

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-0286-2016 Class II — Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional (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-0273-2016 Class II — Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injecti (September 12, 2015)
  • D-0283-2016 Class II — Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate (September 12, 2015)