Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Product description
Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
Lot numbers, UPCs & expiration codes
Lot # 64340EV, exp 07/2018 ACE ITEM # 1671018
Where it was sold
Product was distributed throughout the United States.
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-0071-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 24, 2017
- FDA report date
- Nov 15, 2017
- Quantity
- 200 vials (25 mislabeled vials)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ace Surgical Supply Co., Inc.
Original FDA data
Every field from FDA enforcement report D-0071-2018, exactly as published.
Show all FDA fields
- City
- Brockton
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 78376
- Address
- 1034 Pearl St
- Code information
- Lot # 64340EV, exp 07/2018 ACE ITEM # 1671018
- Postal code
- 02301-5411
- Report date
- Nov 15, 2017
- Product type
- Drugs
- Recall number
- D-0071-2018
- Classification
- Class II
- Recalling firm
- Ace Surgical Supply Co., Inc.
- Product quantity
- 200 vials (25 mislabeled vials)
- Termination date
- Mar 20, 2018
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Oct 24, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 7, 2017