The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1041-2013·Announced 2013-09-25

Leiter's Pharmacy Recalls Lidocaine/Phenylephrine Vials Due to Sterility Concerns

Leiter's Pharmacy is recalling 728 vials of Lidocaine/Phenylephrine PF 1%/1.5% injectible solution because sterility cannot be assured after failed test results were incorrectly reported as passing.

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 source text identifies the recall as FDA Class II and cites bacterial contamination/sterility failure, which aligns with the rubric criterion for 'FDA Class II with hospitalization reports' or significant injury/property-damage reports, warranting a score of 4.

Plain-English summary

Leiter's Pharmacy is recalling 728 vials of Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial. The product was compounded by Leiter's Compounding Pharmacy in San Jose, California, and distributed nationwide. The specific lot number is 07302013@6 with an expiration date of 10/28/13.

The recall was initiated due to a lack of assurance of sterility. An investigation revealed that a contract testing laboratory reported out-of-specification (OOS) or failed results to customers as passing. Consequently, the sterility of these products cannot be assured, posing a risk of bacterial contamination.

Consumers and healthcare providers should stop using the affected vials immediately. The FDA classifies this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Manufacturer
Leiter's Pharmacy
Category
Drug — Injectable Compounded Drug
Hazard
Affected units
728

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 (1)

  • Lot # : 07302013@6 Exp 10/28/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Leiter's Pharmacy 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 4 products in this recall →

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