Mallinckrodt Recalls MD Gastroview Due to Labeling Errors
Mallinckrodt is recalling 6,600 bottles of MD Gastroview because some bottles have incorrect or missing lot numbers and expiration dates.
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 minor labeling errors (incorrect or missing lot/expiration dates) without reported injuries or illnesses, fitting the 'Moderate' severity criteria for low-risk contamination or labeling issues.
Plain-English summary
Mallinckrodt, Inc. is recalling 6,600 bottles of MD Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP). The recall is due to labeling errors where some bottles have incorrect or missing lot numbers and/or expiration dates.
The affected product is a prescription drug used for gastrointestinal radiography, available in 30 mL single-unit containers. The specific lots involved are B201B (expiring April 2015) and B346D (expiring August 2015). The distribution pattern for this recall is listed as Costa Rica.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations. No adverse health consequences are expected from this labeling defect.
The recalled product
- Product
- MD GASTROVIEW (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
- Brand
- MD GASTROVIEW
- Manufacturer
- Mallinckrodt, Inc.
- Hazard
- Affected units
- 6,600
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 (4)
- Lot #: B201B
- Exp April 2015
- B346D
- Exp August 2015.
UPCs (1)
- 0300194816044
Distribution
Distribution scope not specified by the agency.
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