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Class II: temporary or reversible health riskTerminated

Compounded Solutions in Pharmacy 20% Acetyl-L-Cysteine Ophthalmic Solutions Recall

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

Compounded Solutions in Pharmacy · Monroe, CT

Risk level
Class II
Reported by FDA
Sep 18, 2019
Recall ID
D-1853-2019
Check your lot numberHow we source this data

Summary

Compounded Solutions in Pharmacy recalled 20% Acetyl-L-Cysteine Ophthalmic Solutions starting Sep 3, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1853-2019 on Sep 18, 2019. Reason: Lack of Processing Controls:. Status: Terminated.

Why it was recalled

Lack of Processing Controls:

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Product was dispensed to patients

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1853-2019
Classification
Class II
Status
Terminated
Recall initiated
Sep 3, 2019
FDA report date
Sep 18, 2019
Quantity
3x3 ml dropper bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Compounded Solutions in Pharmacy

Original FDA data

Every field from FDA enforcement report D-1853-2019, exactly as published.

Show all FDA fields
City
Monroe
State
CT
Status
Terminated
Country
United States
Event ID
83722
Address
810 Main St
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
Postal code
06468-2809
Report date
Sep 18, 2019
Product type
Drugs
Recall number
D-1853-2019
Classification
Class II
Recalling firm
Compounded Solutions in Pharmacy
Product quantity
3x3 ml dropper bottles
Termination date
Mar 4, 2020
Reason for recall
Lack of Processing Controls:
Voluntary / mandated
Voluntary: Firm initiated
Product description
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
Distribution pattern
Product was dispensed to patients
Recall initiation date
Sep 3, 2019
Initial firm notification
Telephone
Center classification date
Sep 12, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1853-2019, published Sep 18, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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