The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0705-2018·Announced 2018-05-09

AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

AuroMedics Pharma LLC is recalling 261,250 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

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 a confirmed report of mold and leaking bags in an intravenous product, which poses a significant risk of serious injury or adverse health consequences.

Plain-English summary

AuroMedics Pharma LLC is recalling 261,250 bags of Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 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 lots involved include CLV160016, CLV160017, and CLV160018 (expiring September 2018); CLV160019 (expiring October 2018); CLV160020, CLV160021, and CLV160031 (expiring November 2018); CLV160032 and CLV170001 (expiring December 2018); CLV170008 and CLV170009 (expiring April 2019); and CLV170020, CLV170021, and CLV170022 (expiring October 2019).

Healthcare providers and patients should stop using the affected product and contact AuroMedics Pharma LLC or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
Brand
LEVETIRACETAM
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Prescription Drug
Hazard
Affected units
261,250

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 (17)

  • Lot/Batch #'s: CLV160016
  • CLV160017
  • and CLV160018
  • exp Sept 2018
  • CLV160019
  • exp Oct 2018
  • CLV160020
  • CLV160021
  • and CLV160031
  • exp Nov 2018
  • CLV160032 and CLV170001
  • exp 12/18
  • CLV170008 and CLV170009
  • exp April 2019
  • CLV170020
  • CLV170021 and CLV170022
  • 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 →

Related recalls

Same brand · LEVETIRACETAM

Same manufacturer · AuroMedics Pharma LLC

See all →

Same hazard · sterility

See all →

Similar recalls