Advanced Pharma Recalls Nitroglycerin Due to Latex Labeling Error
Advanced Pharma Inc. is recalling all strengths and dosage forms of Nitroglycerin because the product labeling may not correctly disclose the presence of synthetic or natural latex.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a labeling error regarding latex content. There are no reported illnesses or injuries in the source text, and the hazard is theoretical until exposure occurs, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Nitroglycerin, covering all strengths, all dosage forms, and all packaging. The product is prescription-only and was distributed nationwide in the United States. The recall is limited to all lots within their expiration dates.
The reason for the recall is a labeling issue. The source text indicates that the products may contain synthetic latex and/or natural latex, but the labeling is classified as 'Not Elsewhere Classified' regarding this specific hazard. This suggests a potential failure to properly disclose the presence of latex, which is a known allergen.
Consumers and healthcare providers should check their inventory of Nitroglycerin from Advanced Pharma Inc. If the product is found, it should be held and not administered to patients with known latex allergies until further notice. Patients should consult their healthcare provider for alternative treatments if they are concerned about latex exposure.
The recalled product
- Product
- Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Cardiovascular
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 60 products in this recall →Related recalls
Same manufacturer · Advanced Pharma Inc.
See all →- HighAdvanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
FDA (Drugs) · 2019-05-08
- SevereAdvanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- HighAdvanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
Same hazard · latex allergen
See all →- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateHalyard Total Joint Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits Due to Latex Labeling Error
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOASIS MRI table pads recalled for missing latex allergen labeling
FDA (Devices) · 2021-09-01