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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Leiter's Compounding is recalling Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride Injection, 1 mL Total Volume in a 2 mL Vial (Preservative Free). The recall involves 76,315 total units distributed nationwide. The affected products have expiration dates ranging from 09/24/2016 to 02/06/2017.
The recall is being conducted due to a lack of assurance of sterility. The source text indicates that all compounded products within the expiry period were produced using recalled filters.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- Leiter's Compounding
- Category
- Drug — Injectable
- Hazard
- Affected units
- 76,315
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All unexpired lots
- Expirations dates of 09/24/2016 to 02/06/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Leiter's Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Leiter's Compounding
See all →- SevereLeiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereFDA Recalls Lidocaine and Phenylephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereLeiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereLeiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereLeiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereLeiter's Recalls Cefuroxime Intravitreal Injection Due to Incorrect Formulation
FDA (Drugs) · 2019-03-13
- SevereSodium Phosphate Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
- HighCeftazidime Intravitreal Solution Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- SevereLidocaine/Sodium Chloride Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
- SevereLeiter's Pharmacy Recalls Dextrose 50% Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereLeiter's Pharmacy Recalls Lidocaine/Phenylephrine Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-25