Why it was recalled
Discoloration: Product complaints of discoloration after reconstitution of vials.
Product description
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
Lot numbers, UPCs & expiration codes
Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
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-0574-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 25, 2019
- FDA report date
- Dec 18, 2019
- Quantity
- 275,060 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0574-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84356
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
- Postal code
- 08520-1401
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0574-2020
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 275,060 vials
- Termination date
- Mar 4, 2021
- Reason for recall
- Discoloration: Product complaints of discoloration after reconstitution of vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2019