Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported December 9, 2015
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
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Geritrex Corp recalled Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) N… - a moderate-severity action.
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) N… was recalled by Geritrex Corp in December 9, 2015. Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misb…. Check the official notice for the remedy. Verify recall #D-0393-2016 with the FDA Drug before acting.
The recall
Geritrex Corp issued this moderate-severity FDA Drug recall-Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misb….
- Moderate
- severity level
- Class II
- classification
- December 9, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0393-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0393-2016) was formally reported on December 9, 2015, with the manufacturer initiating the action on October 27, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Geritrex Corp is listed as the recalling firm, operating out of Mount Vernon, NY. Federal records list the affected scope as 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350.
The documented reason for this recall is: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0393-2016 |
| Date reported | December 9, 2015 |
| Date initiated | October 27, 2015 |
| Recalling firm | Geritrex Corp |
| Firm location | Mount Vernon, NY |
| Affected scope | 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350 |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0393-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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. Recalled by Geritrex Corp. Units affected: 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350.
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2015. Severity: Moderate. Recall number: D-0393-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0393-2016) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 9, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.