The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0072-2021·Announced 2020-11-18

H & H Remedies Recalls White Liniment Due to CGMP Deviations

H & H Remedies, LLC is voluntarily recalling 365 bottles of White Liniment due to Current Good Manufacturing Practice (CGMP) deviations.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).

Plain-English summary

H & H Remedies, LLC is voluntarily recalling 365 bottles of White Liniment. The product is packaged in 1 oz, 4 oz, and 6 oz bottles and was manufactured and sold by H & H Remedies, LLC, located in New Philadelphia, Ohio. The recall covers lot numbers H20-01W through H20-84W.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The product was distributed nationwide in the United States. Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
Manufacturer
H & H Remedies, LLC
Category
Drug — Topical Medication
Hazard
Affected units
365

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 (1)

  • Lot #: H20-01W thru H20-84W

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by H & H Remedies, LLC 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 3 products in this recall →

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