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Class II: temporary or reversible health riskTerminated

PharMEDium Services HYDROmorphone HCl 0 Recall

HYDROmorphone HCl 0

PharMEDium Services, LLC · Dayton, NJ

Risk level
Class II
Reported by FDA
Jun 20, 2018
Recall ID
D-0854-2018
Check your lot numberHow we source this data

Summary

PharMEDium Services recalled HYDROmorphone HCl 0 starting Jun 5, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0854-2018 on Jun 20, 2018. Reason: Superpotent and Subpotent. Status: Terminated.

Why it was recalled

Superpotent and Subpotent

Product description

HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ

Lot numbers, UPCs & expiration codes

Lot numbers: 180820005D, exp 6/21/2018; 180990007D, exp 7/8/2018; and 181000020D, exp 7/9/2018

Where it was sold

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-0854-2018
Classification
Class II
Status
Terminated
Recall initiated
Jun 5, 2018
FDA report date
Jun 20, 2018
Quantity
2,800 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
PharMEDium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0854-2018, exactly as published.

Show all FDA fields
City
Dayton
State
NJ
Status
Terminated
Country
United States
Event ID
80251
Address
36 Stults Rd
Code information
Lot numbers: 180820005D, exp 6/21/2018; 180990007D, exp 7/8/2018; and 181000020D, exp 7/9/2018
Postal code
08810
Report date
Jun 20, 2018
Product type
Drugs
Recall number
D-0854-2018
Classification
Class II
Recalling firm
PharMEDium Services, LLC
Product quantity
2,800 syringes
Termination date
Feb 6, 2019
Reason for recall
Superpotent and Subpotent
Voluntary / mandated
Voluntary: Firm initiated
Product description
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
Distribution pattern
Nationwide
Recall initiation date
Jun 5, 2018
Initial firm notification
Telephone
Center classification date
Jun 8, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0854-2018, published Jun 20, 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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