Recalls / Class I
Class ID-0710-2021
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
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
- Affected lot / code info
- 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
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
- 466 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-0710-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.