Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Product description
HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
Lot numbers, UPCs & expiration codes
Lot Numbers: 151200003M, 151260128M, 151300005M, 151310094M, 151320134M, 151320143M, 151340107M, 151370002M, 151390005M, 151390142M, 151400005M, 151400095M, 151400136M, 151470008M, 151510002M, 151520080M, 151880214M, 151890257M, Exp between 07/15/15-10/12/15
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-0050-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2015
- FDA report date
- Oct 19, 2016
- Quantity
- 1916 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0050-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73925
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot Numbers: 151200003M, 151260128M, 151300005M, 151310094M, 151320134M, 151320143M, 151340107M, 151370002M, 151390005M, 151390142M, 151400005M, 151400095M, 151400136M, 151470008M, 151510002M, 151520080M, 151880214M, 151890257M, Exp between 07/15/15-10/12/15
- Postal code
- 60045-2506
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0050-2017
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 1916 syringes
- Termination date
- Jun 23, 2017
- Reason for recall
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 17, 2015
- Initial firm notification
- Center classification date
- Oct 12, 2016