Efficient Laboratories Recalls Rompe Pecho CF Cold & Flu Due to Microbial Contamination
Efficient Laboratories is recalling 5,249 bottles of Rompe Pecho CF Cold & Flu with Honey due to microbial contamination. The product was distributed nationwide in the USA.
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, which corresponds to a 'Severe' severity score under the rubric, as it involves a risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Efficient Laboratories, Inc. is recalling 5,249 bottles of Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL). The recall is due to microbial contamination of non-sterile products. The specific lot number is 19H359 with an expiration date of August 2022.
The product was distributed nationwide in the USA. The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8
- Manufacturer
- Efficient Laboratories, Inc.
- Category
- Drug — OTC Cold & Flu
- 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: 19H359 Exp. August 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.
See all 3 products in this recall →Related recalls
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