Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported August 18, 2021
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
Med Shop Total Care Inc. recalled BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop … - a critical-severity action.
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop … was recalled by Med Shop Total Care Inc. in August 18, 2021. Reason: Non-Sterility. Check the official notice for the remedy. Verify recall #D-0704-2021 with the FDA Drug before acting.
The recall
Med Shop Total Care Inc. issued this critical-severity FDA Drug recall-Non-Sterility.
- Critical
- severity level
- Class I
- classification
- August 18, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0704-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0704-2021) was formally reported on August 18, 2021, with the manufacturer initiating the action on October 5, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. Med Shop Total Care Inc. is listed as the recalling firm, operating out of Longview, TX. Federal records list the affected scope as 21 mL.
The documented reason for this recall is: Non-Sterility Distribution data in the federal record shows the product reached: Texas and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
21 mL
Related Recalls
6
0 from same agency
Product description
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Reason for recall
Non-Sterility
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0704-2021 |
| Date reported | August 18, 2021 |
| Date initiated | October 5, 2020 |
| Recalling firm | Med Shop Total Care Inc. |
| Firm location | Longview, TX |
| Affected scope | 21 mL |
| Distribution | Texas and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0704-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605. Recalled by Med Shop Total Care Inc.. Units affected: 21 mL.
Why was this product recalled? ▼
Non-Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 18, 2021. Severity: Critical. Recall number: D-0704-2021.
Where was the recalled product distributed? ▼
Distribution: Texas and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0704-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported August 18, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.