FDA Recall D-0710-2021
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 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
Reason for recall
Non-Sterility
Recall record
- Recall number
D-0710-2021- 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