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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83722

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 03, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Compounded Solutions in Pharmacy

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.

D-1853-2019
Recall number
D-1853-2019
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
3x3 ml dropper bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls:

Code information

Lots: 07172019@39 exp: 8/31/19, Rx # 215042 06192019@28 exp: 7/03/19, Rx # 219335 06052019@8 exp: 6/19/19; Rx # 222826

Distribution pattern

Product was dispensed to patients

drug · product 2 of 3

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

D-1854-2019
Recall number
D-1854-2019
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
a) 6x5ml b) 4x10 c) 1x15 ml bottles,

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

drug · product 3 of 3

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

D-1855-2019
Recall number
D-1855-2019
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
a) 4x5 ml, b) 1x10 ml bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls:

Code information

Lots a) 07182019@29 exp: 8/31/19, 07082019@2 exp: 8/31/19, 06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19; b) 07022019@28 exp: 8/31/19

Distribution pattern

Product was dispensed to patients