FDA Drug recall D-0995-2016
M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 8…
- FDA Drug
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 8… by Well Care Compounding Pharmacy, citing lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0995-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-17 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Well Care Compounding Pharmacy |
| Distribution | NV |
Product
M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Identifiers
| code_info | Lot #: 01222016:57@21, Exp.03/33/2016; Lot #: 01222016: 78@51, Exp.04/25/2016; Lot #: 01272016:51@23, Exp. 03/27/201…Lot #: 01222016:57@21, Exp.03/33/2016; Lot #: 01222016: 78@51, Exp.04/25/2016; Lot #: 01272016:51@23, Exp. 03/27/2016; Lot #: 02292016:71@13, Exp. 04/29/2016; Lot #: 03022016:46@14, Exp. 06/22/2016; Lot #:04252016:20@62, Exp.06/24/2016; Lot #: 04262016:18@11, Exp.06/25/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0995-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.