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Class II: temporary or reversible health riskTerminated

Western Drug 17-Hydroxyprogesterone 250mg/mL Injection Recall

17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc

Western Drug · Springerville, AZ

Risk level
Class II
Reported by FDA
Dec 9, 2015
Recall ID
D-0472-2016
Check your lot numberHow we source this data

Summary

Western Drug recalled 17-Hydroxyprogesterone 250mg/mL Injection starting Oct 19, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0472-2016 on Dec 9, 2015. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Lot numbers, UPCs & expiration codes

all lots

Where it was sold

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

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-0472-2016
Classification
Class II
Status
Terminated
Recall initiated
Oct 19, 2015
FDA report date
Dec 9, 2015
Quantity
41 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Western Drug

Original FDA data

Every field from FDA enforcement report D-0472-2016, exactly as published.

Show all FDA fields
City
Springerville
State
AZ
Status
Terminated
Country
United States
Event ID
72520
Address
105 W Main St
Code information
all lots
Postal code
85938-7203
Report date
Dec 9, 2015
Product type
Drugs
Recall number
D-0472-2016
Classification
Class II
Recalling firm
Western Drug
Product quantity
41 containers
Termination date
Oct 1, 2016
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Distribution pattern
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
Recall initiation date
Oct 19, 2015
Initial firm notification
Telephone
Center classification date
Dec 1, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0472-2016, published Dec 9, 2015. 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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