FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

PharMEDium Services 0.2% Ropivacaine HCI Recall

0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yello…

PharMEDium Services, LLC · Dayton, NJ

Risk level
Class II
Reported by FDA
Feb 21, 2018
Recall ID
D-0423-2018
Check your lot numberHow we source this data

Summary

PharMEDium Services recalled 0.2% Ropivacaine HCI starting Feb 5, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0423-2018 on Feb 21, 2018. Reason: Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin. Status: Terminated.

Why it was recalled

Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

Product description

0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC

Lot numbers, UPCs & expiration codes

Lot #: 180030029D, Exp 2/18/18

Where it was sold

Product was distributed to SC, FL, NY, NY,WA

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-0423-2018
Classification
Class II
Status
Terminated
Recall initiated
Feb 5, 2018
FDA report date
Feb 21, 2018
Quantity
21 Cassettes
Recall type
Voluntary: Firm initiated
Recalling firm
PharMEDium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0423-2018, exactly as published.

Show all FDA fields
City
Dayton
State
NJ
Status
Terminated
Country
United States
Event ID
79063
Address
36 Stults Rd
Code information
Lot #: 180030029D, Exp 2/18/18
Postal code
08810
Report date
Feb 21, 2018
Product type
Drugs
Recall number
D-0423-2018
Classification
Class II
Recalling firm
PharMEDium Services, LLC
Product quantity
21 Cassettes
Termination date
Apr 24, 2018
Reason for recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Distribution pattern
Product was distributed to SC, FL, NY, NY,WA
Recall initiation date
Feb 5, 2018
Initial firm notification
Letter
Center classification date
Mar 29, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0423-2018, published Feb 21, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls