Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
National Drug Code
Is NDC 63323-0469-01 recalled?
Haloperidol Decanoate · 1 VIAL in 1 CARTON (63323-469-01) / 1 mL in 1 VIAL
Yes — this exact package was recalled
2 FDA recalls name the code 63323-0469-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Haloperidol Decanoate
- Strength
- HALOPERIDOL DECANOATE 50 mg/mL
- Form
- Injection · Intramuscular
- Labeler
- Fresenius Kabi USA, LLC
- Type
- Human Prescription Drug
- Product code
- 63323-0469
Recalls naming this package
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 63323-0162 Ketorolac Tromethamine 4
- 63323-0010 Gentamicin 2
- 63323-0184 Folic Acid 2
- 63323-0186 Sodium Chloride 2
- 63323-0269 Diprivan 2
- 63323-0365 See recall 2
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