Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400...

FDA Drug Recall #D-0930-2017 — Class III — February 15, 2017

Recall Summary

Recall Number D-0930-2017
Classification Class III — Low risk
Date Initiated February 15, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pharmedium Services Llc
Location Lake Forest, IL
Product Type Drugs
Quantity 79 I.V. pumps

Product Description

Ropivacaine HCl 0.2% 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: 61553-256-09

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Distribution Pattern

Nationwide

Lot / Code Information

Lot: 170340164s Lot: 170380152s Ex.: 01/1/1900

Other Recalls from Pharmedium Services Llc

Recall # Classification Product Date
D-0931-2017 Class III Ropivacaine HCl 0.2% 500 mL Total Volume in an ... Feb 15, 2017
D-0933-2017 Class III Ropivacaine HCl 0.2% 750 mL Total Volume in an ... Feb 15, 2017
D-0932-2017 Class III Ropivacaine HCl 0.2% 500 mL Total Volume in an ... Feb 15, 2017
D-0935-2017 Class III Bupivacaine HCl 0.25% 270 mL Total Volume in an... Feb 15, 2017
D-0936-2017 Class III Bupivacaine HCl 0.25% 400 mL Total Volume in an... Feb 15, 2017

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.