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Class II: temporary or reversible health riskTerminated

Avella of Deer Valley, Inc. Store 38 PHENYLephrine 10 mg Recall

PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0

Avella of Deer Valley, Inc. Store 38 · Phoenix, AZ

Risk level
Class II
Reported by FDA
Jul 25, 2018
Recall ID
D-0965-2018
Check your lot numberHow we source this data

Summary

Avella of Deer Valley, Inc. Store 38 recalled PHENYLephrine 10 mg starting Jun 12, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0965-2018 on Jul 25, 2018. Reason: Lack of Assurance of Sterility: Potential leakage of bags. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Potential leakage of bags.

Product description

PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25

Lot numbers, UPCs & expiration codes

Lot #: 4/30/18 0732 558-85625P, BUD 6/29/2018 .

Where it was sold

Nationwide in the USA

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-0965-2018
Classification
Class II
Status
Terminated
Recall initiated
Jun 12, 2018
FDA report date
Jul 25, 2018
Quantity
40 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Avella of Deer Valley, Inc. Store 38

Original FDA data

Every field from FDA enforcement report D-0965-2018, exactly as published.

Show all FDA fields
City
Phoenix
State
AZ
Status
Terminated
Country
United States
Event ID
80307
Address
24416 N 19th Ave
Code information
Lot #: 4/30/18 0732 558-85625P, BUD 6/29/2018 .
Postal code
85085-1887
Report date
Jul 25, 2018
Product type
Drugs
Recall number
D-0965-2018
Classification
Class II
Recalling firm
Avella of Deer Valley, Inc. Store 38
Product quantity
40 bags
Termination date
Jan 24, 2020
Reason for recall
Lack of Assurance of Sterility: Potential leakage of bags.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
Distribution pattern
Nationwide in the USA
Recall initiation date
Jun 12, 2018
Initial firm notification
Letter
Center classification date
Jul 19, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0965-2018, published Jul 25, 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.

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