Why it was recalled
Lack of Assurance of Sterility; media fill failure at manufacturer
Product description
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
Lot numbers, UPCs & expiration codes
Lots: 171390026D Exp. 08/20/2017; 171370064D Exp. 8/16/2017; 171390027D Exp. 8/20/2017; 171420074D Exp. 8/21/2017; 171430062D Exp. 8/22/2017; 171440058D Exp. 8/23/2017; 171450001D Exp. 8/23/2017; 171450002D Exp. 8/23/2017; 171450056D Exp. 08/24/2017
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-0985-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2017
- FDA report date
- Jul 26, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMedium Services, Llc
Original FDA data
Every field from FDA enforcement report D-0985-2017, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77634
- Address
- 12620 W Airport Blvd Ste 130
- Code information
- Lots: 171390026D Exp. 08/20/2017; 171370064D Exp. 8/16/2017; 171390027D Exp. 8/20/2017; 171420074D Exp. 8/21/2017; 171430062D Exp. 8/22/2017; 171440058D Exp. 8/23/2017; 171450001D Exp. 8/23/2017; 171450002D Exp. 8/23/2017; 171450056D Exp. 08/24/2017
- Postal code
- 77478-6200
- Report date
- Jul 26, 2017
- Product type
- Drugs
- Recall number
- D-0985-2017
- Classification
- Class II
- Recalling firm
- PharMedium Services, Llc
- Termination date
- Apr 29, 2020
- Reason for recall
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 26, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jul 14, 2017