FDA (Drugs) recall action 75230

Leiter's Compounding recalled 9 products on 2016-10-19

The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2016-10-19
Critical: 0
Units: 686,835

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

SevereFDA (Drugs)··2016-10-19
Leiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns
Leiter's Compounding is recalling Moxifloxacin intravitreal injections because they were produced using recalled filters, raising concerns about sterility.
Product
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
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0 states
SevereFDA (Drugs)··2016-10-19
Leiter's Compounding Recalls Brilliant Blue G Injection Due to Sterility Concerns
Leiter's Compounding is recalling Brilliant Blue G injections because they were produced using recalled filters, raising concerns about sterility.
Product
Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
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0 states
SevereFDA (Drugs)··2016-10-19
FDA Recalls Lidocaine and Phenylephrine Injection Due to Sterility Concerns
Leiter's Compounding is recalling Lidocaine HCl and Phenylephrine HCl injection vials because they were produced using recalled filters, raising concerns about sterility.
Product
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
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0 states
SevereFDA (Drugs)··2016-10-19
Leiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns
Leiter's Compounding is recalling Vancomycin 10 mg/mL injection vials because they were produced using recalled filters, raising concerns about sterility.
Product
Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
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0 states
SevereFDA (Drugs)··2016-10-19
Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns
Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.
Product
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose…
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0 states
SevereFDA (Drugs)··2016-10-19
Leiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns
Leiter's Compounding is recalling Atropine Sulfate 0.01% ophthalmic solution because the filters used to produce the products were recalled, raising concerns about sterility.
Product
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
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0 states
SevereFDA (Drugs)··2016-10-19
Leiter's Compounding Recalls Mitomycin Injection Due to Sterility Concerns
Leiter's Compounding is recalling Mitomycin 0.02% injections because the filters used to produce them were recalled, raising concerns about sterility.
Product
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
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0 states
SevereFDA (Drugs)··2016-10-19
Leiter's Compounding Recalls Cefuroxime Sodium Injection Due to Sterility Concerns
Leiter's Compounding is recalling Cefuroxime Sodium Injection because products were made with recalled filters, raising sterility concerns.
Product
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
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0 states
SevereFDA (Drugs)··2016-10-19
Leiter's Compounds Recalls Prednisolone Placebo Due to Sterility Concerns
Leiter's Compounding is recalling placebo ophthalmic suspensions because they were produced using recalled filters, raising concerns about sterility.
Product
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
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0 states