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Class II: temporary or reversible health riskTerminated

Pharmedium Services Phenylephrine HCL 100 mcg per mL Recall

Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jan 24, 2018
Recall ID
D-0221-2018
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled Phenylephrine HCL 100 mcg per mL starting Sep 26, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0221-2018 on Jan 24, 2018. Reason: Superpotent Drug. Status: Terminated.

Why it was recalled

Superpotent Drug

Product description

Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20

Lot numbers, UPCs & expiration codes

Lot #: 172560019M, Exp. 12/13/2017

Where it was sold

Nationwide within the US

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-0221-2018
Classification
Class II
Status
Terminated
Recall initiated
Sep 26, 2017
FDA report date
Jan 24, 2018
Quantity
2390 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0221-2018, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
78695
Address
150 N Field Dr Ste 350
Code information
Lot #: 172560019M, Exp. 12/13/2017
Postal code
60045-2506
Report date
Jan 24, 2018
Product type
Drugs
Recall number
D-0221-2018
Classification
Class II
Recalling firm
Pharmedium Services, LLC
Product quantity
2390 syringes
Termination date
May 7, 2020
Reason for recall
Superpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
Distribution pattern
Nationwide within the US
Recall initiation date
Sep 26, 2017
Initial firm notification
Telephone
Center classification date
Jan 12, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0221-2018, published Jan 24, 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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