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Class II: temporary or reversible health riskTerminated

Pallimed Solutions Alprostadil IN NS Injection Recall

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

Pallimed Solutions · Woburn, MA

Risk level
Class II
Reported by FDA
Aug 21, 2013
Recall ID
D-858-2013
Check your lot numberHow we source this data

Summary

Pallimed Solutions recalled Alprostadil IN NS Injection starting Mar 25, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-858-2013 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

Alprostadil IN NS Injection, 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-858-2013
Classification
Class II
Status
Terminated
Recall initiated
Mar 25, 2013
FDA report date
Aug 21, 2013
Quantity
408 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Pallimed Solutions

Original FDA data

Every field from FDA enforcement report D-858-2013, 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-858-2013
Classification
Class II
Recalling firm
Pallimed Solutions
Product quantity
408 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
Alprostadil IN NS Injection, 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-858-2013, 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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