FDA Drug recall D-1854-2019
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
- FDA Drug
- Class II
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles by Compounded Solutions In Pharmacy, citing lack of Processing Controls:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1854-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-03 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Compounded Solutions In Pharmacy |
| Distribution | n/a |
Product
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Reason
Lack of Processing Controls:
Identifiers
| code_info | Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19…Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1854-2019%22
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