Why it was recalled
Non-Sterility
Product description
FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Lot numbers, UPCs & expiration codes
Lot #: 09282020@75 BUD: 10/27/2020
Where it was sold
Texas and Puerto Rico
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-0707-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 5, 2020
- FDA report date
- Aug 18, 2021
- Quantity
- 21 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Med Shop Total Care Inc.
Original FDA data
Every field from FDA enforcement report D-0707-2021, exactly as published.
Show all FDA fields
- City
- Longview
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 88291
- Address
- 470 E Loop 281
- Code information
- Lot #: 09282020@75 BUD: 10/27/2020
- Postal code
- 75605-7939
- Report date
- Aug 18, 2021
- Product type
- Drugs
- Recall number
- D-0707-2021
- Classification
- Class I
- Recalling firm
- Med Shop Total Care Inc.
- Product quantity
- 21 mL
- Termination date
- Aug 17, 2023
- Reason for recall
- Non-Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
- Distribution pattern
- Texas and Puerto Rico
- Recall initiation date
- Oct 5, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 9, 2021