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Class II: temporary or reversible health riskTerminated

Geritrex Gericare Iron Supplement Elixir Ferrous Recall

Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz

Geritrex, LLC · Middletown, NY

Risk level
Class II
Reported by FDA
Jul 31, 2019
Recall ID
D-1523-2019
Check your lot numberHow we source this data

Summary

Geritrex recalled Gericare Iron Supplement Elixir Ferrous starting May 31, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1523-2019 on Jul 31, 2019. Reason: cGMP Deviations: Products may have microbial contamination. Status: Terminated.

Why it was recalled

cGMP Deviations: Products may have microbial contamination.

Product description

Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16

Lot numbers, UPCs & expiration codes

Lot #: 70601, Exp 6/19

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-1523-2019
Classification
Class II
Status
Terminated
Recall initiated
May 31, 2019
FDA report date
Jul 31, 2019
Quantity
3789 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Geritrex, LLC

Original FDA data

Every field from FDA enforcement report D-1523-2019, exactly as published.

Show all FDA fields
City
Middletown
State
NY
Status
Terminated
Country
United States
Event ID
83200
Address
40 Commercial Ave
Code information
Lot #: 70601, Exp 6/19
Postal code
10941-1444
Report date
Jul 31, 2019
Product type
Drugs
Recall number
D-1523-2019
Classification
Class II
Recalling firm
Geritrex, LLC
Product quantity
3789 bottles
Termination date
Feb 2, 2024
Reason for recall
cGMP Deviations: Products may have microbial contamination.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16
Distribution pattern
U.S.A. Nationwide
Recall initiation date
May 31, 2019
Initial firm notification
Letter
Center classification date
Jul 25, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1523-2019, published Jul 31, 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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