Why it was recalled
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Product description
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Lot numbers, UPCs & expiration codes
Lot EG6023, Exp. 07/01/2022
Where it was sold
Nationwide in the USA, Puerto Rico, and Guam
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-0626-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 3, 2021
- FDA report date
- Jun 9, 2021
- Quantity
- 163,957 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PFIZER, INC
Original FDA data
Every field from FDA enforcement report D-0626-2021, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87837
- Address
- 275 N Field Dr Bldg H3-3N
- Code information
- Lot EG6023, Exp. 07/01/2022
- Postal code
- 60045-2579
- Report date
- Jun 9, 2021
- Product type
- Drugs
- Recall number
- D-0626-2021
- Classification
- Class I
- Recalling firm
- PFIZER, INC
- Product quantity
- 163,957 vials
- Termination date
- Apr 4, 2023
- Reason for recall
- Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
- Distribution pattern
- Nationwide in the USA, Puerto Rico, and Guam
- Recall initiation date
- May 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2021