AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns
AuroMedics Pharma LLC is recalling 67,300 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 infection.
Plain-English summary
AuroMedics Pharma LLC is recalling 67,300 bags of Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), for intravenous infusion. The recall is being conducted 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 are CLV160004, CLV160005, and CLV160006 (expiring September 2018), as well as CLV170011, CLV170015, and CLV170016 (expiring June 2019). The product is identified by NDC 55150-248-47.
Healthcare providers and patients should stop using the affected product and contact AuroMedics Pharma LLC for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
- Brand
- LEVETIRACETAM
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Anticonvulsant
- Affected units
- 67,300
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 (6)
- Lot/Batch #'s: CLV160004
- CLV160005
- and CLV160006 exp September 2018
- CLV170011
- CLV170015
- CLV170016 exp June 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
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