Mylan Recalls Haloperidol Decanoate Injection Due to Sterility Concerns
Mylan Institutional LLC is recalling Haloperidol Decanoate Injection because leaking vials raised concerns about the product's sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Mylan Institutional LLC is recalling Haloperidol Decanoate Injection, 50 mg/mL, for intra-muscular use. The recall involves 2,523 cartons (25,936 vials) of the medication, which is packaged in 1 mL single-dose vials. The affected lots are 7602368 and 7602369, both with an expiration date of 7/16.
The recall was initiated due to a lack of assurance of sterility caused by leaking vials. The product was distributed nationwide and in Puerto Rico. Haloperidol Decanoate is a prescription-only medication manufactured in India for Mylan Institutional LLC.
Healthcare providers and patients should stop using the affected lots and contact Mylan Institutional LLC for further instructions or replacement products. Consumers should not use the recalled medication and should consult their healthcare provider regarding alternative treatments.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Mylan Institutional LLC
- Hazard
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 7602368
- Exp 7/16
- Lot 7602369
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
Same brand · HALOPERIDOL DECANOATE
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- SevereHaloperidol Decanoate Injection Recalled Due to Sterility Concerns
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- SevereHaloperidol Decanoate Injection Recalled Due to Sterility Concerns
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- SevereHaloperidol Decanoate Injection Recalled for Sterility Assurance Failure
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