Why it was recalled
Superpotent drug: out of specification result for potency
Product description
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
Lot numbers, UPCs & expiration codes
Lot#: 172820134M, Exp 01/18
Where it was sold
CA, IL
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-0080-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 13, 2017
- FDA report date
- Nov 22, 2017
- Quantity
- 499 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMEDium Services, LLC.
Original FDA data
Every field from FDA enforcement report D-0080-2018, exactly as published.
Show all FDA fields
- City
- Memphis
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 78503
- Address
- 6100 Global Dr
- Code information
- Lot#: 172820134M, Exp 01/18
- Postal code
- 38141-8385
- Report date
- Nov 22, 2017
- Product type
- Drugs
- Recall number
- D-0080-2018
- Classification
- Class II
- Recalling firm
- PharMEDium Services, LLC.
- Product quantity
- 499 syringes
- Termination date
- Jan 24, 2020
- Reason for recall
- Superpotent drug: out of specification result for potency
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
- Distribution pattern
- CA, IL
- Recall initiation date
- Oct 13, 2017
- Initial firm notification
- Telephone
- Center classification date
- Nov 14, 2017