FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

SterRx PHENYLepherine HCL in 0 Recall

PHENYLepherine HCL in 0

SterRx, LLC · Plattsburgh, NY

Risk level
Class II
Reported by FDA
Jan 5, 2022
Recall ID
D-0305-2022
Check your lot numberHow we source this data

Summary

SterRx recalled PHENYLepherine HCL in 0 starting Nov 12, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0305-2022 on Jan 5, 2022. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.

Lot numbers, UPCs & expiration codes

S21086/BQW 14-Dec-21 S21149/BTH 23-Jan-22 S21159/BTQ 30-Jan-22 S21265/BXI 3-Apr-22 S21305/BYU 24-Apr-22 S21311/BZA 26-Apr-22

Where it was sold

U.S.A. Nationwide

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-0305-2022
Classification
Class II
Status
Terminated
Recall initiated
Nov 12, 2021
FDA report date
Jan 5, 2022
Quantity
18,948 bags
Recall type
Voluntary: Firm initiated
Recalling firm
SterRx, LLC

Original FDA data

Every field from FDA enforcement report D-0305-2022, exactly as published.

Show all FDA fields
City
Plattsburgh
State
NY
Status
Terminated
Country
United States
Event ID
89059
Address
141 Idaho Ave
Code information
S21086/BQW 14-Dec-21 S21149/BTH 23-Jan-22 S21159/BTQ 30-Jan-22 S21265/BXI 3-Apr-22 S21305/BYU 24-Apr-22 S21311/BZA 26-Apr-22
Postal code
12903-3987
Report date
Jan 5, 2022
Product type
Drugs
Recall number
D-0305-2022
Classification
Class II
Recalling firm
SterRx, LLC
Product quantity
18,948 bags
Termination date
Dec 6, 2023
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Nov 12, 2021
Initial firm notification
Press Release
Center classification date
Dec 29, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0305-2022, published Jan 5, 2022. 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