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Class II: temporary or reversible health riskTerminated

Wells Pharmacy Network Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 Recall

Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded b…

Wells Pharmacy Network LLC · Ocala, FL

Risk level
Class II
Reported by FDA
Jan 11, 2017
Recall ID
D-0364-2017
Check your lot numberHow we source this data

Summary

Wells Pharmacy Network recalled Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 starting Sep 21, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0364-2017 on Jan 11, 2017. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lot numbers, UPCs & expiration codes

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04062016@3, 04252016@4, 05172016@4, 06162016@6, 07212016@8.

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-0364-2017
Classification
Class II
Status
Terminated
Recall initiated
Sep 21, 2016
FDA report date
Jan 11, 2017
Quantity
189 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Wells Pharmacy Network LLC

Original FDA data

Every field from FDA enforcement report D-0364-2017, exactly as published.

Show all FDA fields
City
Ocala
State
FL
Status
Terminated
Country
United States
Event ID
75289
Address
1210 SW 33rd Ave
Code information
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04062016@3, 04252016@4, 05172016@4, 06162016@6, 07212016@8.
Postal code
34474-2853
Report date
Jan 11, 2017
Product type
Drugs
Recall number
D-0364-2017
Classification
Class II
Recalling firm
Wells Pharmacy Network LLC
Product quantity
189 vials
Termination date
Jul 2, 2021
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Distribution pattern
Nationwide
Recall initiation date
Sep 21, 2016
Initial firm notification
Press Release
Center classification date
Jan 4, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0364-2017, published Jan 11, 2017. 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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