Class II · Moderate risk Ongoing
Nitroglycerin Sublingual Tablets 0.3MG
Reason CGMP Deviations
NitroGlycerin
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Subpotent Drug: found to be below the specification for labeled assay.
What was recalled
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.
- Recalling firm
- Advanced Pharma Inc.
- NDC code
- 15082-863-61
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0115-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Nitroglycerin recalls
See all
Class II · Moderate risk Ongoing
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nitrostat
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Nitroglycerin Lingual Spray
Reason Defective Delivery System
Class II · Moderate risk Terminated
Rectiv
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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