Home / Recalls / Leiter's Compounding / D-0010-2017

D-0010-2017 Class II Terminated

Recalled by Leiter's Compounding — San Jose, CA

FDA drug recall D-0010-2017 was initiated by Leiter's Compounding on September 20, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters The recall status is terminated (terminated May 3, 2017). Affected quantity: 76,315 total units, all products.

Recall Details

Product Type
Drugs
Report Date
October 19, 2016
Initiation Date
September 20, 2016
Termination Date
May 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
76,315 total units, all products

Product Description

Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39

Reason for Recall

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Distribution Pattern

Nationwide

Code Information

All unexpired lots; Expirations dates of 11/13/2016 to 01/02/2017

Other recalls by Leiter's Compounding

  • D-0011-2017 Class II — Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in (September 20, 2016)
  • D-0017-2017 Class II — Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compo (September 20, 2016)
  • D-0012-2017 Class II — Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volum (September 20, 2016)
  • D-0013-2017 Class II — Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water (September 20, 2016)
  • D-0015-2017 Class II — Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Tot (September 20, 2016)
  • D-0018-2017 Class II — Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a (September 20, 2016)
  • D-0016-2017 Class II — Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injec (September 20, 2016)
  • D-0014-2017 Class II — Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injec (September 20, 2016)

FDA data resources