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Class II: temporary or reversible health riskTerminated

The Compounding Pharmacy of America Testosterone 100 mg Recall

Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America · Knoxville, TN

Risk level
Class II
Reported by FDA
Sep 23, 2015
Recall ID
D-1742-2015
Check your lot numberHow we source this data

Summary

The Compounding Pharmacy of America recalled Testosterone 100 mg starting Jun 2, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1742-2015 on Sep 23, 2015. Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Product description

Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Lot numbers, UPCs & expiration codes

All lots distributed between November 2014 and May 2015; 01082015@1, 7/7/2015; 11212014@6, 5/20/2015; 11212014@8, 5/20/2015; 1242014@51, 5/23/2015, 11262014@72, 5/25/2015, 01152015@29, 7/14/2015; 02112015@12, 8/10/2015; 12192014@6, 6/17/2015; 12012014@57, 5/30/2015; 12022014@33; 5/31/2015; 12042014@50, 6/2/2015; 12152014@10, 6/13/2015; 12082014@38; 6/6/2015; 12182014@18, 6/16/2015; 12092014@62, 6/7/2015; 12292014@37, 6/27/2015; 12292014@72, 6/29/2015; 01222015@44, 7/21/2015; 01052015@3, 7/4/2015; 01092015@9, 7/8/2015; 01202015@42; 7/19/2015; 04212015@11, 10/18/2015; 01272015@40, 7/26/2015; 01292015@25, 7/28/2015; 01282015@30, 7/27/2015; 02102015@34, 8/9/2015; 02092015@29, 8/8/2015; 02132015@26, 8/12/2015; 02232015@10, 8/22/2015; 02242015@13, 8/23/2015; 02162015@28, 8/15/2015; 04102015@38, 10/7/2015; 05042015@34, 10/31/2015; 02272015@29, 8/26/2015, 03032015@16, 8/30/2015, 03112015@34, 9/7/2015; 03182015@26, 9/14/2015; 03272015@29; 9/23/2015; 04012015@5, 9/28/2015, 04062015@16, 10/3/2015; 04032015@57, 9/30/2015; 04212015@42; 10/18/2015; 05012015@6, 10/28/2015; 05072015@57, 11/3/2015; 05042015@13, 10/31/2015; 04272015@39, 10/24/2015, 04282015@60, 10/25/2015; 05062015@14, 11/2/2015; 05112015@28, 11/7/2015

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-1742-2015
Classification
Class II
Status
Terminated
Recall initiated
Jun 2, 2015
FDA report date
Sep 23, 2015
Quantity
1222 pellets
Recall type
Voluntary: Firm initiated
Recalling firm
The Compounding Pharmacy of America

Original FDA data

Every field from FDA enforcement report D-1742-2015, exactly as published.

Show all FDA fields
City
Knoxville
State
TN
Status
Terminated
Country
United States
Event ID
71371
Address
6216 Highland Place Way Ste 101-A
Code information
All lots distributed between November 2014 and May 2015; 01082015@1, 7/7/2015; 11212014@6, 5/20/2015; 11212014@8, 5/20/2015; 1242014@51, 5/23/2015, 11262014@72, 5/25/2015, 01152015@29, 7/14/2015; 02112015@12, 8/10/2015; 12192014@6, 6/17/2015; 12012014@57, 5/30/2015; 12022014@33; 5/31/2015; 12042014@50, 6/2/2015; 12152014@10, 6/13/2015; 12082014@38; 6/6/2015; 12182014@18, 6/16/2015; 12092014@62, 6/7/2015; 12292014@37, 6/27/2015; 12292014@72, 6/29/2015; 01222015@44, 7/21/2015; 01052015@3, 7/4/2015; 01092015@9, 7/8/2015; 01202015@42; 7/19/2015; 04212015@11, 10/18/2015; 01272015@40, 7/26/2015; 01292015@25, 7/28/2015; 01282015@30, 7/27/2015; 02102015@34, 8/9/2015; 02092015@29, 8/8/2015; 02132015@26, 8/12/2015; 02232015@10, 8/22/2015; 02242015@13, 8/23/2015; 02162015@28, 8/15/2015; 04102015@38, 10/7/2015; 05042015@34, 10/31/2015; 02272015@29, 8/26/2015, 03032015@16, 8/30/2015, 03112015@34, 9/7/2015; 03182015@26, 9/14/2015; 03272015@29; 9/23/2015; 04012015@5, 9/28/2015, 04062015@16, 10/3/2015; 04032015@57, 9/30/2015; 04212015@42; 10/18/2015; 05012015@6, 10/28/2015; 05072015@57, 11/3/2015; 05042015@13, 10/31/2015; 04272015@39, 10/24/2015, 04282015@60, 10/25/2015; 05062015@14, 11/2/2015; 05112015@28, 11/7/2015
Postal code
37919-4068
Report date
Sep 23, 2015
Product type
Drugs
Recall number
D-1742-2015
Classification
Class II
Recalling firm
The Compounding Pharmacy of America
Product quantity
1222 pellets
Termination date
Feb 10, 2016
Reason for recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Distribution pattern
Nationwide
Recall initiation date
Jun 2, 2015
Initial firm notification
Telephone
Center classification date
Sep 15, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1742-2015, published Sep 23, 2015. View the source record (openFDA) · FDA enforcement reports

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

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