The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0706-2018·Announced 2018-05-09

AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

AuroMedics Pharma LLC is recalling Levetiracetam Injection due to a lack of assurance of sterility and a confirmed report of leaking bags and mold.

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 the presence of mold and a lack of sterility assurance in an intravenous product poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

AuroMedics Pharma LLC is recalling 188,941 bags of Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), for intravenous infusion. The recall was initiated due to a lack of assurance of sterility, following a confirmed customer report of leaking bags and mold found between the outer bag and the overwrap.

The affected product is distributed nationwide in the United States. The specific lot numbers involved are CLV160013, CLV160014, and CLV160015 (exp Sept 2018); CLV160022 through CLV160030 (exp Oct 2018); CLV170002 (exp Dec 2018); CLV170010 (exp April 2019); and CLV170027 through CLV170030 (exp Oct 2019). The product is identified by NDC 55150-247-47.

Healthcare providers and patients should stop using the affected lots and contact AuroMedics Pharma LLC for further instructions or to arrange for the return of the product.

The recalled product

Product
LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
Brand
LEVETIRACETAM
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Anticonvulsant
Hazard
Affected units
188,941

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 (19)

  • Lot/Batch #'s: CLV160013
  • CLV160014 and CLV160015
  • exp Sept 2018
  • CLV160022
  • CLV160023
  • CLV160024
  • CLV160025
  • CLV160026
  • CLV160027
  • CLV160028
  • CLV160029
  • CLV160030 exp Oct 2018
  • CLV170002
  • Dec 2018
  • CLV170010
  • exp April 2019
  • CLV170027
  • CLV170028
  • CLV170029 and CLV170030 exp Oct 2019

UPCs (1)

  • 0355150248476

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by AuroMedics Pharma LLC 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 7 products in this recall →

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