Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product description
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Lot numbers, UPCs & expiration codes
193510008D 3/17/2020 193580004D 3/25/020
Where it was sold
Distributed Nationwide in 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-1089-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 16, 2020
- FDA report date
- Apr 15, 2020
- Quantity
- 290 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMEDium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1089-2020, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85212
- Address
- 36 Stults Rd
- Code information
- 193510008D 3/17/2020 193580004D 3/25/020
- Postal code
- 08810
- Report date
- Apr 15, 2020
- Product type
- Drugs
- Recall number
- D-1089-2020
- Classification
- Class II
- Recalling firm
- PharMEDium Services, LLC
- Product quantity
- 290 units
- Termination date
- Feb 14, 2025
- Reason for recall
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Mar 16, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2020