PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported November 17, 2021

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05

Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity

Recall #
D-0228-2022
Affected scope
49
Initiated
October 14, 2021
Compiled from official public sources by the editorial team.
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Golden State Medical Supply Inc. recalled Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured … - a moderate-severity action.

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured … was recalled by Golden State Medical Supply Inc. in November 17, 2021. Reason: Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity. Check the official notice for the remedy. Verify recall #D-0228-2022 with the FDA Drug before acting.

The recall

Golden State Medical Supply Inc. issued this moderate-severity FDA Drug recall-Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity.

Moderate
severity level
49 units
affected scope
Class II
classification
November 17, 2021
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0228-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0228-2022) was formally reported on November 17, 2021, with the manufacturer initiating the action on October 14, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Golden State Medical Supply Inc. is listed as the recalling firm, operating out of Camarillo, CA. Federal records list the affected scope as 49.

The documented reason for this recall is: Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity Distribution data in the federal record shows the product reached: Distributed to two distributors located in AZ and MO. 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

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

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.

Severity

Moderate

Affected scope

49

Related Recalls

6

5 from same agency

Product description

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05

Reason for recall

Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0228-2022
Date reported November 17, 2021
Date initiated October 14, 2021
Recalling firm Golden State Medical Supply Inc.
Firm location Camarillo, CA
Affected scope 49
Distribution Distributed to two distributors located in AZ and MO

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

49 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0228-2022) 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?
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05. Recalled by Golden State Medical Supply Inc.. Units affected: 49.
Why was this product recalled?
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Which agency issued this recall?
This recall was issued by the FDA Drug on November 17, 2021. Severity: Moderate. Recall number: D-0228-2022.
Where was the recalled product distributed?
Distribution: Distributed to two distributors located in AZ and MO.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0228-2022) 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.

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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 November 17, 2021. 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.