Mylan Recalls Haloperidol Decanoate Vials Due to Sterility Concerns
Mylan Institutional LLC is recalling specific lots of Haloperidol Decanoate Injection due to leaking vials that compromise sterility assurance.
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 sterile injectable drug with a sterility assurance failure, which meets the rubric criteria for Severe severity.
Plain-English summary
Mylan Institutional LLC is voluntarily recalling 11,030 cartons (55,150 vials) of Haloperidol Decanoate Injection, 100 mg/mL, for intramuscular use. The affected product is packaged in 1 mL single-dose vials and is available under NDC 67457-409-00 and NDC 67457-409-13. The recall is limited to Lot 7602281 and Lot 7602283, both with an expiration date of 4/16.
The recall was initiated due to a lack of assurance of sterility caused by leaking vials. This defect poses a risk of contamination to the sterile injectable medication. The affected units were distributed nationwide and in Puerto Rico.
Healthcare providers and patients should stop using the affected lots immediately and contact Mylan Institutional LLC or their supplier for further instructions. Patients should consult their healthcare provider regarding alternative treatment options if necessary.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Mylan Institutional LLC
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 (3)
- Lot 7602281
- Exp 4/16
- Lot 7602283
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mylan Institutional 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 2 products in this recall →Related recalls
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