NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single ...
FDA Drug Recall #D-0119-2018 — Class II — June 9, 2017
Recall Summary
| Recall Number | D-0119-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 9, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Pharma Inc. |
| Location | Houston, TX |
| Product Type | Drugs |
| Quantity | 550 syringes |
Product Description
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 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 15082-863-61.
Reason for Recall
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Distribution Pattern
Nationwide in the USA to hospitals and medical facilities.
Lot / Code Information
Lot: 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; 5/18/17 0206 250-86361S, BUD 7/17/17
Other Recalls from Advanced Pharma Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1251-2019 | Class II | HYDROmorphone 20 mg/100 mL Injectable Solution,... | Apr 26, 2019 |
| D-1023-2019 | Class II | Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride... | Mar 13, 2019 |
| D-1017-2019 | Class II | fentaNYL 1000 mcg/100 mL Injectable Solution Fe... | Mar 13, 2019 |
| D-1026-2019 | Class II | 2% Lidocaine HCl Injectable Solution, 60 mg/3 m... | Mar 13, 2019 |
| D-1033-2019 | Class II | Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectab... | Mar 13, 2019 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.