FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Pharm D Solutions Human Chorionic Gonadotropin 3000 IU Recall

Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D

Pharm D Solutions, LLC · Houston, TX

Risk level
Class II
Reported by FDA
Dec 26, 2018
Recall ID
D-0343-2019
Check your lot numberHow we source this data

Summary

Pharm D Solutions recalled Human Chorionic Gonadotropin 3000 IU starting Nov 19, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0343-2019 on Dec 26, 2018. Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Product description

Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10

Lot numbers, UPCs & expiration codes

Lot: 10292018:21 Exp. 3/31/2019

Where it was sold

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-0343-2019
Classification
Class II
Status
Terminated
Recall initiated
Nov 19, 2018
FDA report date
Dec 26, 2018
Quantity
85 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Pharm D Solutions, LLC

Original FDA data

Every field from FDA enforcement report D-0343-2019, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
81629
Address
1304 S Loop W
Code information
Lot: 10292018:21 Exp. 3/31/2019
Postal code
77054-4010
Report date
Dec 26, 2018
Product type
Drugs
Recall number
D-0343-2019
Classification
Class II
Recalling firm
Pharm D Solutions, LLC
Product quantity
85 vials
Termination date
Oct 13, 2020
Reason for recall
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
Distribution pattern
WA
Recall initiation date
Nov 19, 2018
Initial firm notification
Telephone
Center classification date
Dec 20, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0343-2019, published Dec 26, 2018. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls