Why it was recalled
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Product description
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Lot numbers, UPCs & expiration codes
Lot #: 59310DD, Exp 1NOV2017
Where it was sold
Nationwide and Puerto Rico
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-0097-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 16, 2016
- FDA report date
- Oct 19, 2016
- Quantity
- 4768 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc., A Pfizer Company
Original FDA data
Every field from FDA enforcement report D-0097-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 75156
- Address
- 275 N Field Dr
- Code information
- Lot #: 59310DD, Exp 1NOV2017
- Postal code
- 60045-2579
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0097-2017
- Classification
- Class II
- Recalling firm
- Hospira Inc., A Pfizer Company
- Product quantity
- 4768 vials
- Termination date
- Jul 31, 2019
- Reason for recall
- Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 16, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 13, 2016