Why it was recalled
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Product description
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Lot numbers, UPCs & expiration codes
Lot # 59064DK, Exp. 11/17
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-0218-2017
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 4, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 143,250 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc., A Pfizer Company
Original FDA data
Every field from FDA enforcement report D-0218-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 74925
- Address
- 275 N Field Dr
- Code information
- Lot # 59064DK, Exp. 11/17
- Postal code
- 60045-2579
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0218-2017
- Classification
- Class I
- Recalling firm
- Hospira Inc., A Pfizer Company
- Product quantity
- 143,250 vials
- Reason for recall
- Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 4, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2016