FDA Drug recall D-0986-2016
GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
- FDA Drug
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121 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-0986-2016 |
| 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
GLUTATHIONE 100MG/ML, packaged in 10 mL vials, 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 #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016;…Lot #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016; Lot #: 01132016:18@44, Exp. 02/03/2016; Lot #: 01132016:74 @17, Exp. 03/04/2016; Lot #: 01132016:90@9, Exp. 03/04/2016; Lot #: 02222016:34@23, Exp. 04/03/2016; Lot #: 04282016:79@45, Exp. 06/27/2016 |
|---|
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-0986-2016%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.