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Class II: temporary or reversible health riskTerminated

Compounding Centre At Blue Ridge PGE 20 mcg/mL Injectable Recall

PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Cent…

Compounding Centre At Blue Ridge · Raleigh, NC

Risk level
Class II
Reported by FDA
Jan 15, 2014
Recall ID
D-402-2014
Check your lot numberHow we source this data

Summary

Compounding Centre At Blue Ridge recalled PGE 20 mcg/mL Injectable starting Oct 18, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-402-2014 on Jan 15, 2014. Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Product description

PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

NC

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-402-2014
Classification
Class II
Status
Terminated
Recall initiated
Oct 18, 2013
FDA report date
Jan 15, 2014
Quantity
11 units
Recall type
Voluntary: Firm initiated
Recalling firm
Compounding Centre At Blue Ridge

Original FDA data

Every field from FDA enforcement report D-402-2014, exactly as published.

Show all FDA fields
City
Raleigh
State
NC
Status
Terminated
Country
United States
Event ID
66568
Address
2601 Blue Ridge Rd
Code information
All Lots
Postal code
27607-6481
Report date
Jan 15, 2014
Product type
Drugs
Recall number
D-402-2014
Classification
Class II
Recalling firm
Compounding Centre At Blue Ridge
Product quantity
11 units
Termination date
Apr 19, 2017
Reason for recall
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Distribution pattern
NC
Recall initiation date
Oct 18, 2013
Initial firm notification
Telephone
Center classification date
Jan 9, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-402-2014, published Jan 15, 2014. 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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