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Class II · ModerateRecall completed

Rompe Pecho Max Multi Symptoms

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 19G219 Exp. July 2022
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Microbial Contamination of Non-Sterile Products

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byEFFICIENT LABORATORIES INC
Brand nameROMPE PECHO MAX MULTI SYMPTOMS
Generic nameACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN
Active ingredient(s)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Distributed by / forEfficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5
NDC58593-828-08
Show the full FDA record
Full product labelRompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
Recalling firmEfficient Laboratories, Inc.
DistributionNationwide within the United States
Quantity4,026 bottles
Recall initiated2021-08-24
Report date2021-12-29
Recall completed2022-12-08
Recall numberD-0293-2022
ClassificationClass II
FDA statusTerminated
Origin on fileMiami FL United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.