Class II · Moderate risk
Preferred Plus Dioctyl Liquid Stool Softener
cGMP Deviations: Products may have microbial contamination.
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550
Affected NDCs
54162-0335-02
54162-0335-05
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Geritrex Corp
- NDC code
- 54162-335-02
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0393-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Geritrex Corp
All 2015 recalls
Class II · Moderate risk
Gericare Geri-Tussin DM
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Ritussin DM Double Strength
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate
cGMP Deviations: Products may have microbial contamination.
Other unapproved drug recalls from 2015
All unapproved drug recalls
Class II · Moderate risk
GRx HiCort 25
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Carbo-O-Philic 40 Gel 40%
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Carbo-O-Philic 40 Cream 40%
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class I · High risk
Xcellerator
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
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