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Class II: temporary or reversible health riskTerminated

Pharm D Solutions Testosterone 200 mg/mL Recall

Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D

Pharm D Solutions, LLC · Houston, TX

Risk level
Class II
Reported by FDA
Jun 19, 2019
Recall ID
D-1336-2019
Check your lot numberHow we source this data

Summary

Pharm D Solutions recalled Testosterone 200 mg/mL starting May 23, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1336-2019 on Jun 19, 2019. Reason: Lack of Sterility Assurance. Status: Terminated.

Why it was recalled

Lack of Sterility Assurance.

Product description

Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30

Lot numbers, UPCs & expiration codes

Lot #: 10242018:70/B Exp. 08/31/2019; 10302018:63/A Exp. 08/31/2019

Where it was sold

Nationwide within the United States

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-1336-2019
Classification
Class II
Status
Terminated
Recall initiated
May 23, 2019
FDA report date
Jun 19, 2019
Quantity
704 vials
Recall type
FDA Mandated
Recalling firm
Pharm D Solutions, LLC

Original FDA data

Every field from FDA enforcement report D-1336-2019, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
82941
Address
1304 S Loop W
Code information
Lot #: 10242018:70/B Exp. 08/31/2019; 10302018:63/A Exp. 08/31/2019
Postal code
77054-4010
Report date
Jun 19, 2019
Product type
Drugs
Recall number
D-1336-2019
Classification
Class II
Recalling firm
Pharm D Solutions, LLC
Product quantity
704 vials
Termination date
Feb 5, 2021
Reason for recall
Lack of Sterility Assurance.
Voluntary / mandated
FDA Mandated
Product description
Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30
Distribution pattern
Nationwide within the United States
Recall initiation date
May 23, 2019
Initial firm notification
Press Release
Center classification date
Jun 7, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1336-2019, published Jun 19, 2019. 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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