Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure
Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.
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 FDA classified this as a Class II recall. The hazard involves lack of assurance of sterility due to confirmed bacterial contamination detected during media fill testing of a parenteral injection product. Sterility failures in injectable drugs pose a direct risk of serious infection, meeting the Severe criteria for Class II recalls with significant potential for patient harm.
Plain-English summary
Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection 100 mg/mL, 1 mL single-dose vials (NDC 68001-581-41 and NDC 68001-581-48, lot numbers A240482A and A240482B, expiration date 08/2026) manufactured for BluePoint Laboratories. The recall was initiated due to lack of assurance of sterility following the detection of bacterial contamination during media fill testing.
Approximately 23,960 vials have been distributed nationwide. This is a prescription injectable medication administered intramuscularly and used in treatment of certain psychiatric conditions. The contamination detected during manufacturing process validation raises concerns about the sterile integrity of affected units.
Patients currently using this medication should consult their healthcare provider or pharmacist immediately. Do not discontinue use without medical guidance, as abrupt discontinuation of this medication may have serious health consequences. Healthcare providers should verify whether their inventory contains affected lot numbers A240482A or A240482B with expiration date 08/2026 and follow appropriate handling instructions.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Category
- Drug — Injectable / Parenteral
- Hazard
- sterility-failure
- bacterial-contamination
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 (5)
- NDC 68001-581-41
- A240482A
- exp. date 08/2026
- NDC 68001-581-48
- A240482B
UPCs (4)
- 0368001578592
- 0368001581417
- 0368001579599
- 0368001582414
Distribution
Distributed nationwide across the United States.
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