FDA Drug recall D-0711-2017
ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
- FDA Drug
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy by Key Pharmacy And Compounding Center, citing lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0711-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-18 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Key Pharmacy And Compounding Center |
| Distribution | US |
Product
ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Identifiers
| code_info | Lot # 01-20-2017@17, Exp 4/20/2017; 01-23-2017@48, Exp 4/23/2017; 01-27-2017@17, Exp 4/27/2017; 01-31-2017@42, Exp 5/1/…Lot # 01-20-2017@17, Exp 4/20/2017; 01-23-2017@48, Exp 4/23/2017; 01-27-2017@17, Exp 4/27/2017; 01-31-2017@42, Exp 5/1/2017; 02-01-2017@35, Exp 5/2/2017; t02-07-2017@67, Exp 5/9/2017. |
|---|
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-0711-2017%22
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