The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1039-2013·Announced 2013-09-25

Leiter's Pharmacy Recalls Hyaluronidase Vials Due to Sterility Concerns

Leiter's Pharmacy is recalling 810 vials of Hyaluron (hyaluronidase) 150 units/mL due to bacterial contamination and unverified sterility.

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 bacterial contamination in a sterile injectable product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Leiter's Pharmacy is recalling 810 vials of Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial. The product was compounded by Leiter's Compounding Pharmacy in San Jose, California, and distributed nationwide. The specific lot number is 06122013@9, with an expiration date of 9/10/13.

The recall was initiated because an investigation at a contract testing laboratory revealed bacterial contamination. The laboratory reported out-of-specification (OOS) results to customers as passing, meaning the sterility of these products cannot be assured.

Consumers and healthcare providers should stop using the affected vials immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Manufacturer
Leiter's Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
810

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 #: 06122013@9
  • Exp 9/10/13

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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