Agency classClass IIOur severity:High FDA (Drugs)·D-1074-2023·Announced 2023-08-09

Lidocaine Injectable Syringes Recalled for Sterilization Assurance Concerns

CAPS Inc. is recalling 9,517 lidocaine 2% injectable syringes distributed nationwide due to lack of sterilization validation data. No illnesses have been reported.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a serious sterilization hazard in an injectable drug product. No illnesses or injuries have been reported, supporting a High severity level per the rubric.

Plain-English summary

Central Admixture Pharmacy Services Inc. (CAPS) is recalling 9,517 syringes of lidocaine 2% injection (20 mg/mL in 5 mL syringes) distributed nationwide. The product is a prescription-only injectable anesthetic.

The recall was initiated due to lack of assurance of sterility. The manufacturer has not provided validation data for sanitization cycles used in manufacturing, meaning there is no documented evidence that the sterilization processes effectively eliminate potential microorganisms from the final product.

Affected lot numbers include 17-271076 through 17-273771 with expiration dates from July 2023 through September 2023. Healthcare facilities and pharmacies that received these syringes should discontinue use immediately and return the product to CAPS Inc. or contact the FDA with questions.

No illnesses or injuries have been reported in connection with this recall. However, sterility failure in injectable products could result in serious infections if contaminated units were used in patient care.

The recalled product

Product: lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable anesthetic
Hazard: sterility-failure
contamination-risk
Affected units: 9,517

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 (20)

Lot: 17-271076
Exp. 7/24/2023
17-271132
17-271165
Exp. 7/25/2023
17-271230
17-271250
Exp. 7/26/2023
17-271508
Exp. 7/31/2023
17-271595
17-271604
Exp. 8/1/2023
17-271658
Exp. 8/2/2023
17-271764
Exp. 8/3/2023
17-271826
Exp. 8/6/2023
17-271972

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Central Admixture Pharmacy Services Inc 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 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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