Why it was recalled
Lack of Assurance of Sterility
Product description
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Lot numbers, UPCs & expiration codes
Lot: a) OXT202, exp 5/31/2025; OXT203, exp 5/31/2025; OXT301, exp 12/31/2025; b) OXT205, exp 6/30/2025; OXT204, exp 5/31/2025
Where it was sold
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-0937-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 11, 2023
- FDA report date
- Aug 2, 2023
- Quantity
- 760 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0937-2023, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 92678
- Address
- 1901 N Roselle Rd Ste 450
- Code information
- Lot: a) OXT202, exp 5/31/2025; OXT203, exp 5/31/2025; OXT301, exp 12/31/2025; b) OXT205, exp 6/30/2025; OXT204, exp 5/31/2025
- Postal code
- 60195-3194
- Report date
- Aug 2, 2023
- Product type
- Drugs
- Recall number
- D-0937-2023
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals
- Product quantity
- 760 bottles
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 11, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2023