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Class II: temporary or reversible health riskTerminated

Ranier's Compounding Laboratory P/P/P Recall

P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL…

Ranier's Compounding Laboratory · Jeannette, PA

Risk level
Class II
Reported by FDA
Aug 22, 2018
Recall ID
D-1093-2018
Check your lot numberHow we source this data

Summary

Ranier's Compounding Laboratory recalled P/P/P starting Jul 25, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1093-2018 on Aug 22, 2018. Reason: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Product description

P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Lot numbers, UPCs & expiration codes

All lots within expiry

Where it was sold

Product was distributed within the state of Pennsylvania.

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-1093-2018
Classification
Class II
Status
Terminated
Recall initiated
Jul 25, 2018
FDA report date
Aug 22, 2018
Quantity
1 vial
Recall type
Voluntary: Firm initiated
Recalling firm
Ranier's Compounding Laboratory

Original FDA data

Every field from FDA enforcement report D-1093-2018, exactly as published.

Show all FDA fields
City
Jeannette
State
PA
Status
Terminated
Country
United States
Event ID
80633
Address
1107 Lowry Ave
Code information
All lots within expiry
Postal code
15644-3030
Report date
Aug 22, 2018
Product type
Drugs
Recall number
D-1093-2018
Classification
Class II
Recalling firm
Ranier's Compounding Laboratory
Product quantity
1 vial
Termination date
Sep 1, 2022
Reason for recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Voluntary / mandated
Voluntary: Firm initiated
Product description
P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Distribution pattern
Product was distributed within the state of Pennsylvania.
Recall initiation date
Jul 25, 2018
Initial firm notification
Letter
Center classification date
Aug 15, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1093-2018, published Aug 22, 2018. View the source record (openFDA) · FDA enforcement reports

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

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