Qualitest Recalls Ampicillin Capsules Due to Unapproved Labeling
Vintage Pharmaceuticals LLC is recalling 360 bottles of Ampicillin Capsules, USP, 250 mg, because they are labeled with unapproved labeling.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The hazard is limited to unapproved labeling.
Plain-English summary
Vintage Pharmaceuticals LLC, doing business as Qualitest Pharmaceuticals, is recalling 360 bottles of Ampicillin Capsules, USP, 250 mg. The product is identified by NDC 67253-180-50, Lot # 52217, and an expiration date of 04/18. The bottles contain 500 capsules each and are prescription-only.
The recall was initiated because the product is labeled with unapproved labeling. The specific nature of the unapproved labeling is described in the source as 'Incorrect Or Missing Package Insert.'
The affected product was distributed in the United States, including Ohio. Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If found, the product should be returned to the pharmacy or supplier for disposal or credit, as directed by the recalling firm.
The recalled product
- Product
- AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 360
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 (2)
- Lot #: 52217
- Expiry: 04/18
Distribution
Distributed in 1 state:
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