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Recall Observatory FDA recall evidence

Drug product

10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

D-1854-2019

September 03, 2019

Class II

Product summary

Firm
Compounded Solutions in Pharmacy
Event
Event 83722
Status
Terminated
Classification
Class II
Quantity
a) 6x5ml b) 4x10 c) 1x15 ml bottles,
Official record key
drug-enforcement:D-1854-2019

Official wording

Reason: Lack of Processing Controls:

Code information: 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

Distribution pattern: Product was dispensed to patients

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls