Recalls / Class I
Class ID-0706-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
- Affected lot / code info
- Lot #: 09302020@67 BUD: 10/29/2020
Why it was recalled
Non-Sterility
Recalling firm
- Firm
- Med Shop Total Care Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 470 E Loop 281, N/A, Longview, Texas 75605-7939
Distribution
- Quantity
- 21 mL
- Distribution pattern
- Texas and Puerto Rico
Timeline
- Recall initiated
- 2020-10-05
- FDA classified
- 2021-08-09
- Posted by FDA
- 2021-08-18
- Terminated
- 2023-08-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0706-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.