FDA Recall D-0713-2021
Med Shop Total Care Inc. · Longview, TX
Class I — life-threatening Terminated 1046 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Reason for recall
Non-Sterility
Recall record
- Recall number
D-0713-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Texas and Puerto Rico
- Recall initiated
- 2020-10-05
- Classified by FDA Center
- 2021-08-09
- FDA published
- 2021-08-18
- Terminated
- 2023-08-17
- Recalling firm
- Med Shop Total Care Inc.
- Firm location
- Longview, TX