Why it was recalled
Non-Sterility
Product description
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Lot numbers, UPCs & expiration codes
Lot #: a) 09302020@40, BUD 10/28/2020, b) 09292020@55, BUD 10/27/2020, c) 09302020@58, BUD 10/29/2020, d) 10012020@6, e) 09302020@23, f)10012020@4, g) 10012020@11 BUD 10/29/2020, h) 10012020@64, i)10022020@22, j) 10012020@15 BUD 10/30/2020, k) 10012020@41 BUD 10/29/2020, l) 09282020@92, BUD 10/27/2020, m)10012020@20 BUD 10/30/2020, n) 09302020@9, BUD 10/28/2020, o) 09292020@36, BUD 10/27/2020, p) 09302020@11, q) 09302020@18, BUD 10/28/2020
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-0717-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 5, 2020
- FDA report date
- Aug 18, 2021
- Quantity
- 360 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Med Shop Total Care Inc.
Original FDA data
Every field from FDA enforcement report D-0717-2021, 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 #: a) 09302020@40, BUD 10/28/2020, b) 09292020@55, BUD 10/27/2020, c) 09302020@58, BUD 10/29/2020, d) 10012020@6, e) 09302020@23, f)10012020@4, g) 10012020@11 BUD 10/29/2020, h) 10012020@64, i)10022020@22, j) 10012020@15 BUD 10/30/2020, k) 10012020@41 BUD 10/29/2020, l) 09282020@92, BUD 10/27/2020, m)10012020@20 BUD 10/30/2020, n) 09302020@9, BUD 10/28/2020, o) 09292020@36, BUD 10/27/2020, p) 09302020@11, q) 09302020@18, BUD 10/28/2020
- Postal code
- 75605-7939
- Report date
- Aug 18, 2021
- Product type
- Drugs
- Recall number
- D-0717-2021
- Classification
- Class I
- Recalling firm
- Med Shop Total Care Inc.
- Product quantity
- 360 mL
- Termination date
- Aug 17, 2023
- Reason for recall
- Non-Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, 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