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Class II: temporary or reversible health riskTerminated

Pallimed Solutions DMSO Aqueous Irrigation 50% Recall

DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA

Pallimed Solutions · Woburn, MA

Risk level
Class II
Reported by FDA
Aug 21, 2013
Recall ID
D-867-2013
Check your lot numberHow we source this data

Summary

Pallimed Solutions recalled DMSO Aqueous Irrigation 50% starting Mar 25, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-867-2013 on Aug 21, 2013. Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. Status: Terminated.

Why it was recalled

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

Product description

DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA

Lot numbers, UPCs & expiration codes

All lots within expiry

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-867-2013
Classification
Class II
Status
Terminated
Recall initiated
Mar 25, 2013
FDA report date
Aug 21, 2013
Quantity
3 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Pallimed Solutions

Original FDA data

Every field from FDA enforcement report D-867-2013, exactly as published.

Show all FDA fields
City
Woburn
State
MA
Status
Terminated
Country
United States
Event ID
64716
Address
400 W Cummings Park
Code information
All lots within expiry
Postal code
01801-6519
Report date
Aug 21, 2013
Product type
Drugs
Recall number
D-867-2013
Classification
Class II
Recalling firm
Pallimed Solutions
Product quantity
3 vials
Termination date
Aug 21, 2013
Reason for recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Voluntary / mandated
Voluntary: Firm initiated
Product description
DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Distribution pattern
Nationwide
Recall initiation date
Mar 25, 2013
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Aug 9, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-867-2013, published Aug 21, 2013. 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.

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