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Class II: temporary or reversible health riskTerminated

Vann Healthcare Services Hydroxyprogesterone Caproate Recall

Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1…

Vann Healthcare Services Inc · Glasgow, KY

Risk level
Class II
Reported by FDA
Dec 31, 2014
Recall ID
D-0309-2015
Check your lot numberHow we source this data

Summary

Vann Healthcare Services recalled Hydroxyprogesterone Caproate starting Oct 14, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0309-2015 on Dec 31, 2014. Reason: Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Product description

Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Lot numbers, UPCs & expiration codes

Lot #: 071714A

Where it was sold

KY

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-0309-2015
Classification
Class II
Status
Terminated
Recall initiated
Oct 14, 2014
FDA report date
Dec 31, 2014
Quantity
1 vial
Recall type
Voluntary: Firm initiated
Recalling firm
Vann Healthcare Services Inc

Original FDA data

Every field from FDA enforcement report D-0309-2015, exactly as published.

Show all FDA fields
City
Glasgow
State
KY
Status
Terminated
Country
United States
Event ID
69633
Address
1220 N Race St
Code information
Lot #: 071714A
Postal code
42141-3462
Report date
Dec 31, 2014
Product type
Drugs
Recall number
D-0309-2015
Classification
Class II
Recalling firm
Vann Healthcare Services Inc
Product quantity
1 vial
Termination date
Jul 1, 2015
Reason for recall
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Distribution pattern
KY
Recall initiation date
Oct 14, 2014
Initial firm notification
Letter
Center classification date
Dec 19, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0309-2015, published Dec 31, 2014. 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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