Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Ampicillin and Sulbactam for Injection (Ampicillin Sodium and Sulbactam Sodium)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
Affected NDC
55150-0117-20
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 and Sulbactam Ampicillin Sodium and Sulbactam Sodium NDC 55150-0117 |
AMPICILLIN SODIUM 2 g/1; SULBACTAM SODIUM 1 g/1 | Injection, Powder, for Solution Intramuscular|intravenous |
Eugia US LLC | Rx |
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55150-117-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0866-2018 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 AuroMedics Pharma LLC
All 2018 recalls
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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