Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Product description
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
Lot numbers, UPCs & expiration codes
Lot: 170300146s; Exp. 01/01/1900
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-0936-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 15, 2017
- FDA report date
- Jul 12, 2017
- Quantity
- 7 I.V. pumps
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services Llc
Original FDA data
Every field from FDA enforcement report D-0936-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77374
- Address
- 150 N Field Dr
- Code information
- Lot: 170300146s; Exp. 01/01/1900
- Postal code
- 60045-4847
- Report date
- Jul 12, 2017
- Product type
- Drugs
- Recall number
- D-0936-2017
- Classification
- Class III
- Recalling firm
- Pharmedium Services Llc
- Product quantity
- 7 I.V. pumps
- Termination date
- Jan 13, 2020
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 15, 2017
- Initial firm notification
- Telephone
- Center classification date
- Jul 2, 2017