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Class II: temporary or reversible health riskTerminated

Natures Pharmacy & Compounding Center Tetracaine 0 Recall

Tetracaine 0

Natures Pharmacy & Compounding Center · Asheville, NC

Risk level
Class II
Reported by FDA
Mar 12, 2014
Recall ID
D-1133-2014
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Summary

Natures Pharmacy & Compounding Center recalled Tetracaine 0 starting Nov 1, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1133-2014 on Mar 12, 2014. Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Status: Terminated.

Why it was recalled

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Product description

Tetracaine 0.5% ophth.

Lot numbers, UPCs & expiration codes

All lot numbers within expiry.

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-1133-2014
Classification
Class II
Status
Terminated
Recall initiated
Nov 1, 2013
FDA report date
Mar 12, 2014
Recall type
Voluntary: Firm initiated
Recalling firm
Natures Pharmacy & Compounding Center

Original FDA data

Every field from FDA enforcement report D-1133-2014, exactly as published.

Show all FDA fields
City
Asheville
State
NC
Status
Terminated
Country
United States
Event ID
66856
Address
752 Biltmore Ave
Code information
All lot numbers within expiry.
Postal code
28803-2558
Report date
Mar 12, 2014
Product type
Drugs
Recall number
D-1133-2014
Classification
Class II
Recalling firm
Natures Pharmacy & Compounding Center
Termination date
Apr 24, 2014
Reason for recall
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Tetracaine 0.5% ophth.
Distribution pattern
NC
Recall initiation date
Nov 1, 2013
Initial firm notification
Telephone
Center classification date
Mar 4, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1133-2014, published Mar 12, 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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