Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Ampicillin for Injection (Ampicillin Sodium)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
Affected NDCs
0781-3407-78
0781-3407-95
Compare with the code on your package — it is the most precise check available.
Drug: Ampicillin
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 |
|---|---|---|---|---|
| Ampicillin Ampicillin sodium NDC 00781-3407 |
500 mg/1 | Injection, Powder, for Solution Intramuscular|intravenous |
Sandoz Inc | Rx |
- Recalling firm
- Sandoz Inc
- NDC code
- 0781-3407-78
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1179-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ampicillin recalls
See all
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Other recalls by Sandoz Inc
All 2017 recalls
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class I · High risk
Buffered Penicillin G Potassium for Injection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
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