Rompe Pecho EX Expectorant Recalled for Microbial Contamination
Efficient Laboratories, Inc. is recalling 5,387 bottles of Rompe Pecho EX Expectorant due to microbial contamination. Consumers should stop using the product and return it to the place 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, which corresponds to a 'Severe' rating under the rubric for significant injury or potential adverse health consequences.
Plain-English summary
Efficient Laboratories, Inc. is recalling 5,387 bottles of Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL). The product is identified by Lot 19F332 and an expiration date of June 2022. The recall is being conducted due to microbial contamination of the non-sterile product.
The affected product was distributed nationwide in the USA. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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
- Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
- Manufacturer
- Efficient Laboratories, Inc.
- Category
- Drug — Expectorant
- 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: 19F332 Exp. June 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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