Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported March 12, 2014
Acetylcysteine 10% ophthalmic
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a…
Natures Pharmacy & Compounding Center recalled Acetylcysteine 10% ophthalmic - a moderate-severity action.
Acetylcysteine 10% ophthalmic was recalled by Natures Pharmacy & Compounding Center in March 12, 2014. Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due…. Check the official notice for the remedy. Verify recall #D-1099-2014 with the FDA Drug before acting.
The recall
Natures Pharmacy & Compounding Center issued this moderate-severity FDA Drug recall-Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due….
- Moderate
- severity level
- Class II
- classification
- March 12, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1099-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1099-2014) was formally reported on March 12, 2014, with the manufacturer initiating the action on November 1, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Natures Pharmacy & Compounding Center is listed as the recalling firm, operating out of Asheville, NC. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance t… Distribution data in the federal record shows the product reached: NC. 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
Unknown
Related Recalls
6
5 from same agency
Product description
Acetylcysteine 10% ophthalmic
Reason for recall
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1099-2014 |
| Date reported | March 12, 2014 |
| Date initiated | November 1, 2013 |
| Recalling firm | Natures Pharmacy & Compounding Center |
| Firm location | Asheville, NC |
| Affected scope | Not disclosed |
| Distribution | NC |
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-1099-2014) 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? ▼
Acetylcysteine 10% ophthalmic. Recalled by Natures Pharmacy & Compounding Center.
Why was this product recalled? ▼
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 12, 2014. Severity: Moderate. Recall number: D-1099-2014.
Where was the recalled product distributed? ▼
Distribution: NC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1099-2014) 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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Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
Lupin Pharmaceuticals Inc. · 2026-05-27
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 March 12, 2014. 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.