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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: NitroGlycerin Injection Syringes Recalled for Subpotency and Stability Issues

Agency Publication Date: December 20, 2017
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Summary

Advanced Pharma Inc. is recalling approximately 7,000 NitroGlycerin injection syringes because the medication was found to be subpotent, meaning it contains less active drug than labeled. Additionally, stability data for certain lots does not support the current expiration dates when stored in the syringe container system. This recall affects multiple doses and sizes of NitroGlycerin in 5% Dextrose, which were distributed nationwide to hospitals and medical facilities.

Risk

Subpotent nitroglycerin may not provide the intended therapeutic effect, which is critical during emergency cardiac events where precise dosing is required to manage chest pain or blood pressure. The lack of stability data also means the drug's effectiveness cannot be guaranteed through its listed expiration date.

What You Should Do

  1. Check your medical facility inventory for NitroGlycerin 1 mg/10 mL (NDC 15082-818-61) with lot numbers 4/17/17 0857 81861S (BUD 08/15/2017), 3/3/17 1830 81861S (BUD 07/01/17), or 3/27/17 0658 81861S (BUD 7/25/17).
  2. Check for NitroGlycerin 1 mg/5 mL (NDC 15082-863-67) with lots: 4/10/17 1441 257-86367S (BUD 6/9/17), 4/17/17 0950 86367S (BUD 6/16/2017), 4/20/17 1505 257-86367S (BUD 6/19/2017), 4/24/17 0115 15-86367S (BUD 6/23/2017), 4/26/17 0301 387-86367S (BUD 6/25/2017), 4/26/17 0730 20-86367S (BUD 6/25/17), 4/24/17 0106 241-86367S (BUD 6/23/17), 5/1/17 1500 45-86367S (BUD 6/30/17), 5/9/17 1103 241-86367S (BUD 7/8/17), 5/9/17 1104 257-86367S (BUD 7/8/17), 5/12/17 0839 15-86367S (BUD 7/11/17), 5/19/17 0109 15-86367S (BUD 7/18/17), 5/22/17 0828 387-86367S (BUD 7/21/17), 5/23/17 0721 257-86367S (BUD 7/22/17), 5/24/17 0200 241-86367S (BUD 7/23/17), 5/24/17 0203 20-86367S (BUD 7/23/17), 5/26/17 0315 15-86367S (BUD 7/25/17), or 5/31/17 1217 20-86367S (BUD 7/30/17).
  3. Check for NitroGlycerin 2 mg/10 mL (NDC 15082-863-61) with lots: 4/19/17 1445 248-86361S (BUD 6/18/2017), 4/20/17 0307 265-86361S (BUD 6/19/17), 4/26/17 0732 265-86361S (BUD 6/25/17), 4/28/17 0215 265-86361S (BUD 6/27/17), 5/2/17 0310 248-86361S (BUD 7/1/17), 5/4/17 1422 248-86361S (BUD 7/3/17), 5/12/17 0841 248-86361S (BUD 7/11/17), or 5/18/17 0206 250-86361S (BUD 7/17/17).
  4. Check for NitroGlycerin 100 mcg/mL QS 5% Dextrose 20 mL (NDC 15082-818-62) with lot 5/31/17 0202 5-81862S (BUD 7/30/17).
  5. If you have affected syringes, immediately stop using them and quarantine the product to ensure it is not administered to patients.
  6. Contact your healthcare provider or pharmacist for guidance regarding alternative medications and return any unused product to the place of purchase for a refund.
  7. For further instructions, contact Advanced Pharma Inc. at their Houston facility located at 9265 Kirby Dr, Houston, Texas, 77054.
  8. If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (NDC 15082-818-61)
Model:
NDC 15082-818-61
Lot Numbers:
4/17/17 0857 81861S (Exp 08/15/2017)
3/3/17 1830 81861S (Exp 07/01/17)
3/27/17 0658 81861S (Exp 7/25/17)
Product: NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (NDC 15082-863-67)
Model:
NDC 15082-863-67
Lot Numbers:
4/10/17 1441 257-86367S (Exp 6/9/17)
4/17/17 0950 86367S (Exp 6/16/2017)
4/20/17 1505 257-86367S (Exp 6/19/2017)
4/24/17 0115 15-86367S (Exp 6/23/2017)
4/26/17 0301 387-86367S (Exp 6/25/2017)
4/26/17 0730 20-86367S (Exp 6/25/17)
4/24/17 0106 241-86367S (Exp 6/23/17)
5/1/17 1500 45-86367S (Exp 6/30/17)
5/9/17 1103 241-86367S (Exp 7/8/17)
5/9/17 1104 257-86367S (Exp 7/8/17)
5/12/17 0839 15-86367S (Exp 7/11/17)
5/19/17 0109 15-86367S (Exp 7/18/17)
5/22/17 0828 387-86367S (Exp 7/21/17)
5/23/17 0721 257-86367S (Exp 7/22/17)
5/24/17 0200 241-86367S (Exp 7/23/17)
5/24/17 0203 20-86367S (Exp 7/23/17)
5/26/17 0315 15-86367S (Exp 7/25/17)
5/31/17 1217 20-86367S (Exp 7/30/17)
Product: NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (NDC 15082-863-61)
Model:
NDC 15082-863-61
Lot Numbers:
4/19/17 1445 248-86361S (Exp 6/18/2017)
4/20/17 0307 265-86361S (Exp 6/19/17)
4/26/17 0732 265-86361S (Exp 6/25/17)
4/28/17 0215 265-86361S (Exp 6/27/17)
5/2/17 0310 248-86361S (Exp 7/1/17)
5/4/17 1422 248-86361S (Exp 7/3/17)
5/12/17 0841 248-86361S (Exp 7/11/17)
5/18/17 0206 250-86361S (Exp 7/17/17)
Product: NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL (NDC 15082-818-62)
Model:
NDC 15082-818-62
Lot Numbers:
5/31/17 0202 5-81862S (Exp 7/30/17)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77503
Status: Resolved
Manufacturer: Advanced Pharma Inc.
Sold By: hospitals; medical facilities
Manufactured In: United States
Units Affected: 7 products (550 syringes; 320 syringes; 50 syringes; 4800 syringes; 50 syringes; 680 syringes; 550 syringes)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.