Advanced Pharma Recalls Labetalol HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling Labetalol HCl products because labels may not properly 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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding latex content, which is a known allergen but does not involve a direct contamination or structural defect in the drug itself.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Labetalol HCl products, including all strengths, dosage forms, and packaging. The recall is limited to prescription-only products manufactured by Avella of Houston, located in Houston, Texas.
The reason for the recall is a labeling defect. The products may contain synthetic latex and/or natural latex, but this information is not properly classified or disclosed on the label. This omission could be a concern for individuals with latex allergies.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for these specific products and contact their pharmacist or the recalling firm for further instructions on how to handle or return the medication.
The recalled product
- Product
- Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Prescription Medication
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 allergy
See all →- ModerateDJO Nylatex Wraps Recalled for Missing Latex Warning Labels
FDA (Devices) · 2020-07-22
- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighCardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
FDA (Devices) · 2019-05-15
- HighCardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
FDA (Devices) · 2019-05-15