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Class II: temporary or reversible health riskCompleted

Altaire Pharmaceuticals ActivEyes Sterile Altalube Ointment Recall

ActivEyes Sterile Altalube Ointment

Altaire Pharmaceuticals, Inc. · Aquebogue, NY

Risk level
Class II
Reported by FDA
Nov 27, 2019
Recall ID
D-0418-2020
Check your lot numberHow we source this data

Summary

Altaire Pharmaceuticals recalled ActivEyes Sterile Altalube Ointment starting Jul 2, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0418-2020 on Nov 27, 2019. Reason: Lack of Assurance of Sterility. Status: Completed.

Why it was recalled

Lack of Assurance of Sterility

Product description

ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50

Lot numbers, UPCs & expiration codes

RJH 10/20 1/10/2018 RLL 12/20 8/22/2018 SGH 07/21 8/23/2018 SIF 09/21 10/16/2018 SKC 11/21 12/12/2018 TCG 03/22

Where it was sold

U.S.A. 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-0418-2020
Classification
Class II
Status
Completed
Recall initiated
Jul 2, 2019
FDA report date
Nov 27, 2019
Quantity
161077 units
Recall type
Voluntary: Firm initiated
Recalling firm
Altaire Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0418-2020, exactly as published.

Show all FDA fields
City
Aquebogue
State
NY
Status
Completed
Country
United States
Event ID
83265
Address
311 W Ln
Address (line 2)
PO Box 849
Code information
RJH 10/20 1/10/2018 RLL 12/20 8/22/2018 SGH 07/21 8/23/2018 SIF 09/21 10/16/2018 SKC 11/21 12/12/2018 TCG 03/22
Postal code
11931-0849
Report date
Nov 27, 2019
Product type
Drugs
Recall number
D-0418-2020
Classification
Class II
Recalling firm
Altaire Pharmaceuticals, Inc.
Product quantity
161077 units
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Jul 2, 2019
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Nov 15, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0418-2020, published Nov 27, 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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