Why it was recalled
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Product description
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Lot numbers, UPCs & expiration codes
Lot #: 151900249M, Exp 09/09/15
Where it was sold
VA, IL, PA, ID
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-1428-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 21, 2015
- FDA report date
- Sep 16, 2015
- Quantity
- 120 cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1428-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71892
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot #: 151900249M, Exp 09/09/15
- Postal code
- 60045-2506
- Report date
- Sep 16, 2015
- Product type
- Drugs
- Recall number
- D-1428-2015
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 120 cassettes
- Termination date
- Sep 11, 2015
- Reason for recall
- Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
- Distribution pattern
- VA, IL, PA, ID
- Recall initiation date
- Jul 21, 2015
- Initial firm notification
- Telephone
- Center classification date
- Sep 10, 2015