Why it was recalled
Presence of particulate matter in solution - black and transparent particles
Product description
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10
Lot numbers, UPCs & expiration codes
Lot #: A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022
Where it was sold
Nationwide 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-0076-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2020
- FDA report date
- Nov 18, 2020
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0076-2021, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86529
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022
- Postal code
- 60015-4625
- Report date
- Nov 18, 2020
- Product type
- Drugs
- Recall number
- D-0076-2021
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Termination date
- May 22, 2023
- Reason for recall
- Presence of particulate matter in solution - black and transparent particles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 7, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 12, 2020