Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date
Product description
HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
Lot numbers, UPCs & expiration codes
Lot: 172410025C; Exp. 11/27/2017
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-0132-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 26, 2017
- FDA report date
- Jan 3, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0132-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78694
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot: 172410025C; Exp. 11/27/2017
- Postal code
- 60045-2506
- Report date
- Jan 3, 2018
- Product type
- Drugs
- Recall number
- D-0132-2018
- Classification
- Class III
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- Unknown
- Termination date
- May 19, 2020
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
- Distribution pattern
- Nationwide.
- Recall initiation date
- Sep 26, 2017
- Initial firm notification
- Telephone
- Center classification date
- Dec 22, 2017