The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1038-2013·Announced 2013-09-25

Leiter's Pharmacy Recalls Dextrose 50% Injection Vials Due to Sterility Concerns

Leiter's Pharmacy is recalling 56 vials of Dextrose 50% Injection Solution because sterility cannot be assured after testing errors were discovered.

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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the text, the potential for serious harm from non-sterile IV products in a Class II context aligns with the Severe criteria.

Plain-English summary

Leiter's Pharmacy is recalling 56 vials of Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration. The product was compounded by Leiter's Compounding Pharmacy in San Jose, California, and distributed nationwide. The specific lot number is 06072013@49, with an expiration date of 9/5/13.

The recall was initiated due to a lack of assurance of sterility. An investigation at a contract testing laboratory revealed that Out of Specification (OOS) results were incorrectly reported to customers as passing. Consequently, the sterility of these products cannot be assured.

Consumers and healthcare providers should stop using the affected vials immediately and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Manufacturer
Leiter's Pharmacy
Category
Drug — IV Solution
Hazard
Affected units
56

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)

  • Lot 06072013@49
  • Exp 9/5/13

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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