Meda Recalls Prefera OB One Gel Capsules Due to Undeclared Ingredients
Meda Pharmaceuticals is recalling Prefera OB One Gel Capsules because the product labeling failed to list several inactive ingredients, including D&C Red #33.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling error regarding undeclared inactive ingredients. Per the rubric, minor labeling errors and low-risk contamination are classified as Moderate.
Plain-English summary
Meda Pharmaceuticals Inc. is recalling Prefera OB One Gel Capsules, 30 softgels, prescription only. The recall involves 478,569 softgel capsules, consisting of 172,740 trade units and 305,829 samples. The product was distributed nationwide.
The recall was initiated because the product labeling did not include several inactive ingredients. Specifically, the labeling failed to disclose the presence of D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, and Purified Water USP.
The source text does not specify which patients or healthcare providers should take specific actions, nor does it report any illnesses or injuries associated with the product. Consumers and healthcare providers should refer to the FDA recall notice for specific instructions on how to handle the affected medication.
The recalled product
- Product
- Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30
- Manufacturer
- Meda Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
Distribution
Distributed nationwide across the United States.
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