New GPC Inc. Recalls Whitfield's Ointment for Labeling Deficiencies
New GPC Inc. is recalling 4,320 units of Whitfield's Ointment B.P. in New York due to missing drug listings and non-compliant labeling.
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 and involves minor labeling errors and regulatory non-compliance (lack of listing/approval) without reports of illness or injury, fitting the Moderate severity criteria.
Plain-English summary
New GPC Inc. has initiated a recall of 4,320 units of Whitfield's Ointment B.P. (15g) manufactured in Guyana. The affected products were distributed in New York and include batch numbers 202504 and 310455.
The recall was issued because the products do not meet monograph requirements. Specifically, the items lack a required drug listing, fail to meet Over-the-Counter (OTC) drug labeling requirements, and are labeled as 'Not Approved for sale in U.S.A.'
Consumers who possess these specific batches of Whitfield's Ointment B.P. should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
- Manufacturer
- New Gpc Inc.
- Category
- Drug — Over-the-Counter Topical
- Affected units
- 4,320
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)
- Batch Numbers: 202504
- 310455
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by New Gpc 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.
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