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Class III: unlikely to cause harmTerminated

Pharm D Solutions Testosterone Cypionate 200 mg/mL in Sesame Recall

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM in…

Pharm D Solutions, LLC · Houston, TX

Risk level
Class III
Reported by FDA
Jan 18, 2017
Recall ID
D-0426-2017
Check your lot numberHow we source this data

Summary

Pharm D Solutions recalled Testosterone Cypionate 200 mg/mL in Sesame starting Oct 12, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0426-2017 on Jan 18, 2017. Reason: Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct. Status: Terminated.

Why it was recalled

Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct

Product description

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04

Lot numbers, UPCs & expiration codes

Lot: 09122016:34, exp 09/07/2017

Where it was sold

AZ and WA

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-0426-2017
Classification
Class III
Status
Terminated
Recall initiated
Oct 12, 2016
FDA report date
Jan 18, 2017
Quantity
4 mL: 510 vials, 5 mL: 486 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Pharm D Solutions, LLC

Original FDA data

Every field from FDA enforcement report D-0426-2017, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
75552
Address
1304 S Loop W
Code information
Lot: 09122016:34, exp 09/07/2017
Postal code
77054-4010
Report date
Jan 18, 2017
Product type
Drugs
Recall number
D-0426-2017
Classification
Class III
Recalling firm
Pharm D Solutions, LLC
Product quantity
4 mL: 510 vials, 5 mL: 486 vials
Termination date
May 11, 2017
Reason for recall
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Voluntary / mandated
Voluntary: Firm initiated
Product description
Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
Distribution pattern
AZ and WA
Recall initiation date
Oct 12, 2016
Initial firm notification
E-Mail
Center classification date
Jan 9, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0426-2017, published Jan 18, 2017. View the source record (openFDA) · FDA enforcement reports

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

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