Why it was recalled
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Product description
Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
Lot numbers, UPCs & expiration codes
Lot #: OXT515, Exp. July 2017
Where it was sold
Nationwide
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-1450-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 13, 2016
- FDA report date
- Aug 3, 2016
- Quantity
- 3990 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1450-2016, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74373
- Address
- 1901 N Roselle Rd Ste 700
- Code information
- Lot #: OXT515, Exp. July 2017
- Postal code
- 60195-3194
- Report date
- Aug 3, 2016
- Product type
- Drugs
- Recall number
- D-1450-2016
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 3990 vials
- Termination date
- Sep 22, 2017
- Reason for recall
- Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 13, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 28, 2016