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Class II: temporary or reversible health riskTerminated

Pharm D Solutions Acetylcysteine Injection 10 mg/5 mL Recall

Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- N…

Pharm D Solutions, LLC · Houston, TX

Risk level
Class II
Reported by FDA
Nov 7, 2018
Recall ID
D-0136-2019
Check your lot numberHow we source this data

Summary

Pharm D Solutions recalled Acetylcysteine Injection 10 mg/5 mL starting Sep 10, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0136-2019 on Nov 7, 2018. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10

Lot numbers, UPCs & expiration codes

Lots: 07032018:93 Discard by: 01/03/2019; 07032018:27 Discard by: 01/03/2019; 07032018:97 Discard by: 01/03/2019

Where it was sold

Nationwide

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-0136-2019
Classification
Class II
Status
Terminated
Recall initiated
Sep 10, 2018
FDA report date
Nov 7, 2018
Quantity
486 milliliters
Recall type
Voluntary: Firm initiated
Recalling firm
Pharm D Solutions, LLC

Original FDA data

Every field from FDA enforcement report D-0136-2019, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
81002
Address
1304 S Loop W
Code information
Lots: 07032018:93 Discard by: 01/03/2019; 07032018:27 Discard by: 01/03/2019; 07032018:97 Discard by: 01/03/2019
Postal code
77054-4010
Report date
Nov 7, 2018
Product type
Drugs
Recall number
D-0136-2019
Classification
Class II
Recalling firm
Pharm D Solutions, LLC
Product quantity
486 milliliters
Termination date
Feb 5, 2021
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
Distribution pattern
Nationwide
Recall initiation date
Sep 10, 2018
Initial firm notification
Press Release
Center classification date
Nov 1, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0136-2019, published Nov 7, 2018. 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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