Why it was recalled
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Product description
Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
Lot numbers, UPCs & expiration codes
Lot #: 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15
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-1823-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 28, 2015
- FDA report date
- Sep 30, 2015
- Quantity
- 20 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1823-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71844
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot #: 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15
- Postal code
- 60045-2506
- Report date
- Sep 30, 2015
- Product type
- Drugs
- Recall number
- D-1823-2015
- Classification
- Class I
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 20 bags
- Termination date
- Jan 27, 2017
- Reason for recall
- Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 28, 2015
- Initial firm notification
- Center classification date
- Sep 23, 2015