FDA Drug recall D-0980-2016
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, 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 ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, 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-0980-2016 |
| 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
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, 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 #: 03252016:11 @26, Exp. 05/07/2016; Lot #: 04042016:28 @39, Exp. 05/06/2016; Lot #: 02102016:00 @22, Exp. 03/24/2…Lot #: 03252016:11 @26, Exp. 05/07/2016; Lot #: 04042016:28 @39, Exp. 05/06/2016; Lot #: 02102016:00 @22, Exp. 03/24/2016; Lot #:02112016:08 @13, Exp. 03/16/2016 |
|---|
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-0980-2016%22
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