CLASS I Drug recall · Reported 18 Aug 2021 · FDA Enforcement Report
Morphine-bupivacaine PF Injectable and syringes recalled
Med Shop Total Care is recalling Morphine-bupivacaine PF Injectable and syringes in various strengths: a) 20MG/Ml-40MG/ML, distributed in Puerto Rico, Texas. The recall was initiated on 5 Oct 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0710-2021
- FDA event ID
- 88291
- Recalling firm
- Med Shop Total Care, Longview, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Oct 2020
- FDA classified
- 9 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 5 Oct 2020 | Recall initiated by company | |
| 9 Aug 2021 | Classified by FDA | +308 days |
| 18 Aug 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.8MG/ML, l) 30MG-10MG/ML, m) 5MG-4MG/ML, n) 10MG/ML-20MG/ML, o) 40MG-5MG/ML, p) 20MG-20MG/ML, q) 30MG-20MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Where it was distributed
Texas and Puerto Rico
Questions about this recall
Why was it recalled?
Non-Sterility
Which lots are affected?
Lot #: a) 09282020@62, BUD 10/27/2020, 09302020@25, BUD 10/29/2020, b) 09292020@56, c) 09292020@58, d)09292020@60, e) 09292020@66, 09292020@73, f) 09292020@70, g) 09292020@71, h) 09292020@77, i) 09302020@20 j) 09302020@33, k) 09302020@48, l) 09302020@61, m) 09302020@66, n) 09302020@70, o) 09302020@26, BUD 10/29/2020, p) 10012020@8, q) 10022020@20, BUD 10/30/2020
Where was it sold?
Texas and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 88291This product is part of a recall event; the main page for the event is Bupivacaine Hcl-baclofen PF Injectable 40MG-4000MCG/ML syringe recalled.
More recalls from Med Shop Total Care
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Fentanyl-bupivacaine Hcl-baclofen PF Injectable recalled | Med Shop Total Care | Sterility | PR, TX |
| Drug | CLASS I | Hydromorphone Hcl-bupivacaine Hcl-sufentanil PF recalled | Med Shop Total Care | Sterility | PR, TX |
| Drug | CLASS I | Sufentanil-bupivacaine-baclofen PF 25MCG-12.5MG-750MCG/ML recalled | Med Shop Total Care | Sterility | PR, TX |
| Drug | CLASS I | Morphine-bupivacaine-ketamine PF Injectable syringe recalled | Med Shop Total Care | Sterility | PR, TX |
| Drug | CLASS I | Morphine-bupivacaine-fentanyl PF 30MG-15MG-2000MCG/ML recalled | Med Shop Total Care | Sterility | PR, TX |