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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot Number AF0117001-A
Where it was sold
distributed nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0339-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 2, 2018
- FDA report date
- Feb 14, 2018
- Quantity
- 53,040 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma Ltd.
Original FDA data
Every field from FDA enforcement report D-0339-2018, exactly as published.
Show all FDA fields
- City
- Hyderabad
- Status
- Terminated
- Country
- India
- Event ID
- 78847
- Address
- Unit Xii, Lactam Formulation Plant
- Address (line 2)
- Survey No. 314, Bachupally, Quthbullapur
- Code information
- Lot Number AF0117001-A
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0339-2018
- Classification
- Class I
- Recalling firm
- Aurobindo Pharma Ltd.
- Product quantity
- 53,040 vials
- Termination date
- Sep 10, 2019
- Reason for recall
- Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- distributed nationwide in the USA
- Recall initiation date
- Jan 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2018