Manufacturer

Leiter's Compounding

9 recalls in our database name Leiter's Compounding as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 9
Most recent: 2016-10-19

Of the 9 recalls from Leiter's Compounding we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

SevereFDA (Drugs)·D-0012-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0016-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0014-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0018-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0010-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0013-2017·2016-10-19
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, C
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0011-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0015-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0017-2017·2016-10-19
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
Category
Drug
Distribution
Distributed nationwide