OTC Cough and Cold Drug Recalled for Microbial Contamination
Efficient Laboratories is recalling approximately 4,026 bottles of Rompe Pecho Max Multi-Symptoms cough and cold medicine nationwide due to potential microbial contamination of the non-sterile product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified by FDA as Class II and involves microbial contamination of an ingested non-sterile drug product, which presents a potential health risk requiring urgent action. Although no illnesses are reported in the source text, the FDA Class II designation and the nature of the contamination hazard elevate this to Severe per the rubric.
Plain-English summary
Efficient Laboratories, Inc. is recalling Rompe Pecho Max Multi-Symptoms Maximum Strength (acetaminophen, dextromethorphan HBr, phenylephrine HCl, and guaifenesin), 8 fl. oz. (237 mL) bottles, due to microbial contamination of this non-sterile product. The recalled product was distributed nationwide within the United States. The affected lot is Lot #19G219 with an expiration date of July 2022.
Consumers should stop using this product and discard any bottles they may have. Consumers with questions or who believe they have been affected should contact Efficient Laboratories, Inc., located in Miami, FL 33166. The product can be identified by UPC 0 00856 00309 5 and NDC 58593-828-08.
The recalled product
- Product
- ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN)
- Brand
- ROMPE PECHO MAX MULTI SYMPTOMS
- Manufacturer
- Efficient Laboratories, Inc.
- Hazard
- microbial-contamination
- non-sterile-product
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 #: 19G219 Exp. July 2022
UPCs (1)
- 000856003095
Distribution
Distributed nationwide across the United States.
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