Recalls / Class I
Class ID-0339-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20
- Brand name
- Ampicillin And Sulbactam
- Generic name
- Ampicillin Sodium And Sulbactam Sodium
- Active ingredients
- Ampicillin Sodium, Sulbactam Sodium
- Route
- Intramuscular, Intravenous
- NDCs
- 55150-116, 55150-117, 55150-178, 55150-179
- FDA application
- ANDA090349
- Affected lot / code info
- Lot Number AF0117001-A
Why it was recalled
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Recalling firm
- Firm
- Aurobindo Pharma Ltd.
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Unit Xii, Lactam Formulation Plant, Survey No. 314, Bachupally, Quthbullapur, Hyderabad, N/A N/A, India
Distribution
- Quantity
- 53,040 vials
- Distribution pattern
- distributed nationwide in the USA
Timeline
- Recall initiated
- 2018-01-02
- FDA classified
- 2018-02-08
- Posted by FDA
- 2018-02-14
- Terminated
- 2019-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0339-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.