Why it was recalled
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Product description
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Lot numbers, UPCs & expiration codes
Lot #: 162790012M, Exp. 1/3/2017
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-0125-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 12, 2016
- FDA report date
- Nov 9, 2016
- Quantity
- 1550 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0125-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 75567
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot #: 162790012M, Exp. 1/3/2017
- Postal code
- 60045-2506
- Report date
- Nov 9, 2016
- Product type
- Drugs
- Recall number
- D-0125-2017
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 1550 units
- Termination date
- Nov 8, 2016
- Reason for recall
- Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 12, 2016
- Initial firm notification
- Telephone
- Center classification date
- Nov 3, 2016