Key Takeaway

Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA by Pallimed Solutions was recalled on March 25, 2013. The hazard: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assu...

FDA Drug Class II Terminated

Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA

Recalled: March 25, 2013 ~12 vials units affected D-880-2013

Description

Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA

Hazard / Reason

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA

Drugs

Company Information

Pallimed Solutions

Woburn, MA, United States

View all 25 recalls by Pallimed Solutions →

Distribution

Nationwide

Related Recalls

FDA Drug Class II

Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA

March 25, 2013
FDA Drug Class II

HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA

March 25, 2013
FDA Drug Class II

Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

March 25, 2013
FDA Drug Class II

Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA

March 25, 2013
FDA Drug Class II

Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

March 25, 2013
FDA Drug Class II

Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA

March 25, 2013

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.