Medications & Supplements/Prescription Drugs

Compounded Solutions in Pharmacy: Acetyl-L-Cysteine Ophthalmic Solutions Recalled for Lack of Processing Controls

Agency Publication Date: September 12, 2019

Summary

Compounded Solutions in Pharmacy is recalling 13 units of Acetyl-L-Cysteine Ophthalmic Solutions (eye drops) in 5%, 10%, and 20% concentrations due to a lack of processing controls. This defect means the medication may not have been prepared under appropriate sterile conditions, which can lead to contamination. The affected eye drops were dispensed in 3ml, 5ml, 10ml, and 15ml dropper bottles directly to patients between June and August 2019.

Risk

A lack of processing controls during the compounding of eye drops can result in products that are not sterile. Using non-sterile eye drops can introduce bacteria or other contaminants directly into the eye, potentially causing serious infections or permanent vision loss.

What You Should Do

Locate your Acetyl-L-Cysteine Ophthalmic Solutions bottle and check the concentration (5%, 10%, or 20%) and the label for specific identification numbers.
For 20% solutions (3ml), check for Lot 07172019@39 (Exp 8/31/19, Rx #215042), Lot 06192019@28 (Exp 7/03/19, Rx #219335), or Lot 06052019@8 (Exp 6/19/19, Rx #222826).
For 10% solutions (5ml, 10ml, or 15ml), check for Lot numbers 08012019@33, 07182019@66, 07182019@15, 07012019@46, 07082019@27, 07082019@55, 07182019@55, 06242019@55, 06202019@16, or 08052019@11 with expiration dates through November 3, 2019.
For 5% solutions (5ml or 10ml), check for Lot numbers 07182019@29, 07082019@2, 06052019@21, 06062019@52, or 07022019@28 with expiration dates through August 31, 2019.
Stop using the eye drops immediately if your bottle matches any of the listed lot numbers or prescription numbers.
Contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment and to report any adverse effects. Return any unused product to the pharmacy for a refund.
Contact Compounded Solutions in Pharmacy at their Monroe, CT location or call the FDA Consumer Complaint hotline at 1-888-723-3332 for further assistance.

Your Remedy Options

Full Refund

Full refund for returned unused product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: 20% Acetyl-L-Cysteine Ophthalmic Solutions (3ml)

Model:

Rx # 215042

Rx # 219335

Rx # 222826

Lot Numbers:

07172019@39 (Exp: 8/31/19)

06192019@28 (Exp: 7/03/19)

06052019@8 (Exp: 6/19/19)

Date Ranges: June 2019 - August 2019

Product: 10% Acetyl-L-Cysteine Ophthalmic Solutions (5ml, 10ml, 15ml)

Lot Numbers:

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)

07082019@55 (Exp: 8/31/19)

07182019@55 (Exp: 08/31/19)

06242019@55 (Exp: 8/31/19)

06202019@16 (Exp: 8/31/19)

08052019@11 (Exp: 11/3/19)

Date Ranges: June 2019 - August 2019

Product: 5% Acetyl-L-Cysteine Ophthalmic Solutions (5ml, 10ml)

Lot Numbers:

07182019@29 (Exp: 8/31/19)

07082019@2 (Exp: 8/31/19)

06052019@21 (Exp: 08/31/19)

06062019@52 (Exp: 6/25/19)

07022019@28 (Exp: 8/31/19)

Date Ranges: June 2019 - August 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83722

Status: Resolved

Manufacturer: Compounded Solutions in Pharmacy

Sold By: Compounded Solutions in Pharmacy

Manufactured In: United States

Units Affected: 3 products (3x3 ml dropper bottles; a) 6x5ml b) 4x10 c) 1x15 ml bottles,; a) 4x5 ml, b) 1x10 ml bottles)

Distributed To: Connecticut

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate your Acetyl-L-Cysteine Ophthalmic Solutions bottle and check the concentration (5%, 10%, or 20%) and the label for specific identification numbers.

For 20% solutions (3ml), check for Lot 07172019@39 (Exp 8/31/19, Rx #215042), Lot 06192019@28 (Exp 7/03/19, Rx #219335), or Lot 06052019@8 (Exp 6/19/19, Rx #222826).

For 10% solutions (5ml, 10ml, or 15ml), check for Lot numbers 08012019@33, 07182019@66, 07182019@15, 07012019@46, 07082019@27, 07082019@55, 07182019@55, 06242019@55, 06202019@16, or 08052019@11 with expiration dates through November 3, 2019.

For 5% solutions (5ml or 10ml), check for Lot numbers 07182019@29, 07082019@2, 06052019@21, 06062019@52, or 07022019@28 with expiration dates through August 31, 2019.

Stop using the eye drops immediately if your bottle matches any of the listed lot numbers or prescription numbers.

Contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment and to report any adverse effects. Return any unused product to the pharmacy for a refund.

Contact Compounded Solutions in Pharmacy at their Monroe, CT location or call the FDA Consumer Complaint hotline at 1-888-723-3332 for further assistance.

Affected Products

Product: 20% Acetyl-L-Cysteine Ophthalmic Solutions (3ml)

Model:

Rx # 215042

Rx # 219335

Rx # 222826

Lot Numbers:

07172019@39 (Exp: 8/31/19)

06192019@28 (Exp: 7/03/19)

06052019@8 (Exp: 6/19/19)

Date Ranges: June 2019 - August 2019

Product: 10% Acetyl-L-Cysteine Ophthalmic Solutions (5ml, 10ml, 15ml)

Lot Numbers:

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)

07082019@55 (Exp: 8/31/19)

07182019@55 (Exp: 08/31/19)

06242019@55 (Exp: 8/31/19)

06202019@16 (Exp: 8/31/19)

08052019@11 (Exp: 11/3/19)

Date Ranges: June 2019 - August 2019

Product: 5% Acetyl-L-Cysteine Ophthalmic Solutions (5ml, 10ml)

Lot Numbers:

07182019@29 (Exp: 8/31/19)

07082019@2 (Exp: 8/31/19)

06052019@21 (Exp: 08/31/19)

06062019@52 (Exp: 6/25/19)

07022019@28 (Exp: 8/31/19)

Date Ranges: June 2019 - August 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83722

Status: Resolved

Manufacturer: Compounded Solutions in Pharmacy

Sold By: Compounded Solutions in Pharmacy

Manufactured In: United States

Units Affected: 3 products (3x3 ml dropper bottles; a) 6x5ml b) 4x10 c) 1x15 ml bottles,; a) 4x5 ml, b) 1x10 ml bottles)

Distributed To: Connecticut