Efficient Laboratories Recalls Rompe Pecho MAX Due to Microbial Contamination
Efficient Laboratories, Inc. is recalling 4,080 bottles of Rompe Pecho MAX Multi Symptoms due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.
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 recall is classified as FDA Class II and involves microbial contamination, which aligns with the rubric criteria for a Severe rating (Score 4) due to the potential for significant health impact.
Plain-English summary
Efficient Laboratories, Inc. is recalling 4,080 bottles of New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL). The product is distributed by Efficient Laboratories, Inc. in Miami, FL, and was distributed nationwide in the USA. The specific lot affected is 19B42 with an expiration date of February 2022. The UPC for the product is 0 00856 00309 5.
The recall is being conducted due to microbial contamination of the non-sterile product. The U.S. Food and Drug Administration has classified this recall as Class II, indicating a situation that could cause temporary or medically reversible health problems, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it immediately. They should return the product to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5
- Manufacturer
- Efficient Laboratories, Inc.
- Category
- Drug — OTC Topical
- Hazard
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: 19B42 Exp. February 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Efficient Laboratories, 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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