JCB Laboratories Recalls Subpotent Cefuroxime Ophthalmic Injection Syringes
JCB Laboratories is recalling 6,510 syringes of Cefuroxime Ophthalmic Solution for Injection because the product is subpotent prior to its expiration date.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety risk like toxicity or infection.
Plain-English summary
JCB Laboratories LLC is recalling 6,510 syringes of Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. The product is a compounded drug intended for hospital and office use only and is not for resale. The recall covers specific lots with beyond-use dates ranging from January 21, 2018, to February 20, 2018.
The recall was initiated because the product is subpotent prior to its 90-day beyond-use date. This means the medication may not contain the full amount of the active ingredient required to be effective. The affected products were distributed nationwide within the United States.
Healthcare facilities and offices that have received this product should stop using it and contact the recalling firm for instructions on return or disposal. Patients who have already received the medication should consult their healthcare provider if they have concerns about the treatment.
The recalled product
- Product
- Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
- Manufacturer
- JCB Laboratories LLC
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 6,510
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 (10)
- Lot #: C274-000002725
- BUD 1/21/2018
- C274-000002790
- BUD 1/28/2018
- C274-000002989
- BUD 2/13/2018
- C274-000003008
- BUD 2/14/2018
- C274-000003077
- BUD 2/20/2018
Distribution
Distributed nationwide across the United States.
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