Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported February 28, 2018
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
American Pharmaceutical Ingredients LLC recalled Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 1… - a moderate-severity action.
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 1… was recalled by American Pharmaceutical Ingredients LLC in February 28, 2018. Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expirati…. Check the official notice for the remedy. Verify recall #D-0492-2018 with the FDA Drug before acting.
The recall
American Pharmaceutical Ingredients LLC issued this moderate-severity FDA Drug recall-CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expirati….
- Moderate
- severity level
- Class II
- classification
- February 28, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0492-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0492-2018) was formally reported on February 28, 2018, with the manufacturer initiating the action on February 9, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. American Pharmaceutical Ingredients LLC is listed as the recalling firm, operating out of Waterford, MI. Federal records list the affected scope as 106200 g.
The documented reason for this recall is: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. Distribution data in the federal record shows the product reached: Nationwide within USA.. 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
106200 g
Related Recalls
6
5 from same agency
Product description
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Reason for recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0492-2018 |
| Date reported | February 28, 2018 |
| Date initiated | February 9, 2018 |
| Recalling firm | American Pharmaceutical Ingredients LLC |
| Firm location | Waterford, MI |
| Affected scope | 106200 g |
| Distribution | Nationwide within USA. |
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-0492-2018) 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? ▼
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327. Recalled by American Pharmaceutical Ingredients LLC. Units affected: 106200 g.
Why was this product recalled? ▼
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2018. Severity: Moderate. Recall number: D-0492-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide within USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0492-2018) 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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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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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 February 28, 2018. 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.