Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported December 27, 2017
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Advanced Pharma Inc. recalled NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile … - a moderate-severity action.
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile … was recalled by Advanced Pharma Inc. in December 27, 2017. Reason: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container sys…. Check the official notice for the remedy. Verify recall #D-0116-2018 with the FDA Drug before acting.
The recall
Advanced Pharma Inc. issued this moderate-severity FDA Drug recall-Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container sys….
- Moderate
- severity level
- Class II
- classification
- December 27, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0116-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0116-2018) was formally reported on December 27, 2017, with the manufacturer initiating the action on June 9, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Advanced Pharma Inc. is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 4800 syringes.
The documented reason for this recall is: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Distribution data in the federal record shows the product reached: Nationwide in the USA to hospitals and medical facilities.. 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 - 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices 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
4800 syringes
Related Recalls
6
0 from same agency
Product description
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Reason for recall
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0116-2018 |
| Date reported | December 27, 2017 |
| Date initiated | June 9, 2017 |
| Recalling firm | Advanced Pharma Inc. |
| Firm location | Houston, TX |
| Affected scope | 4800 syringes |
| Distribution | Nationwide in the USA to hospitals and medical facilities. |
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-0116-2018) 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? ▼
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.. Recalled by Advanced Pharma Inc.. Units affected: 4800 syringes.
Why was this product recalled? ▼
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 27, 2017. Severity: Moderate. Recall number: D-0116-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA to hospitals and medical facilities..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0116-2018) 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.
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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 December 27, 2017. 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.