The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D0035-2015·Announced 2014-10-29

New Gpc Inc. Recalls Rector's Remedy Ointment for Labeling Deficiencies

New Gpc Inc. is recalling Rector's Remedy Ointment because the product lacks required drug listings and OTC labeling.

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 due to labeling and listing deficiencies, which aligns with the rubric for minor labeling errors and voluntary precautionary recalls where no immediate health hazard is reported.

Plain-English summary

New Gpc Inc. has initiated a recall of Rector's Remedy Ointment, 15g, manufactured in Guyana. The recall involves 2,304 units distributed in New York under batch numbers 311478 and 305207.

The FDA has classified this as a Class II recall because the product does not meet monograph requirements. Specifically, the recalled items lack the required drug listing and fail to meet Over-the-Counter (OTC) drug labeling requirements. These are regulatory compliance issues rather than reports of product contamination or manufacturing defects that cause immediate physical harm.

Consumers who have purchased this product should stop using it and contact New Gpc Inc. for further instructions or a refund. The recall is limited to the specific batch numbers and distribution area listed above.

The recalled product

Product
Rector's Remedy OINTMENT, 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
Hazard
Affected units
2,304

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: 311478
  • 305207

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.

See all 7 products in this recall →

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