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Class II: temporary or reversible health riskOngoing

Pharmacy Plus, Inc. dba Vital Care Compounder ACETYLCYSTEINE OPTH 5% Solution Recall

ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S

Pharmacy Plus, Inc. dba Vital Care Compounder · Hattiesburg, MS

Risk level
Class II
Reported by FDA
Nov 9, 2022
Recall ID
D-0027-2023
Check your lot numberHow we source this data

Summary

Pharmacy Plus, Inc. dba Vital Care Compounder recalled ACETYLCYSTEINE OPTH 5% Solution starting Oct 7, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0027-2023 on Nov 9, 2022. Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Product description

ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Lot numbers, UPCs & expiration codes

Lots: 66017, BUD: 10/13/2022; 66177, BUD: 10/19/2022

Where it was sold

AL, LA, MS, and TN

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-0027-2023
Classification
Class II
Status
Ongoing
Recall initiated
Oct 7, 2022
FDA report date
Nov 9, 2022
Quantity
2 droptainers
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmacy Plus, Inc. dba Vital Care Compounder

Original FDA data

Every field from FDA enforcement report D-0027-2023, exactly as published.

Show all FDA fields
City
Hattiesburg
State
MS
Status
Ongoing
Country
United States
Event ID
90982
Address
115 S 40th Ave
Code information
Lots: 66017, BUD: 10/13/2022; 66177, BUD: 10/19/2022
Postal code
39402-6600
Report date
Nov 9, 2022
Product type
Drugs
Recall number
D-0027-2023
Classification
Class II
Recalling firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Product quantity
2 droptainers
Reason for recall
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Voluntary / mandated
Voluntary: Firm initiated
Product description
ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Distribution pattern
AL, LA, MS, and TN
Recall initiation date
Oct 7, 2022
Initial firm notification
Telephone
Center classification date
Nov 2, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0027-2023, published Nov 9, 2022. 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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