Class II · Moderate risk
Haloperidol Lactate Injection
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Haloperidol Decanoate Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; due to leaking vials
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Affected NDCs
67457-0409-00
67457-0409-13
Compare with the code on your package — it is the most precise check available.
Drug: Haloperidol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Haloperidol Decanoate NDC 67457-0409 |
100 mg/mL | Injection Intramuscular |
Mylan Institutional LLC | Rx |
- Recalling firm
- Mylan Institutional LLC
- NDC code
- 67457-409-00
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0421-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Haloperidol recalls
See all
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility: Media fill with bacterial contamination
Other recalls by Mylan Institutional LLC
All 2015 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
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