The Recall Desk
HighFDA (Drugs)·D-0290-2022·Announced 2021-12-29

Rompe Pecho Cold & Flu Syrup Recalled for Microbial Contamination

Efficient Laboratories is recalling Rompe Pecho CF Cold & Flu Advanced Formula syrup due to microbial contamination of the non-sterile product. The recall affects 10,833 bottles distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for microbial contamination of a non-sterile oral product. Although no specific illnesses have been reported in the source text, microbial contamination of a non-sterile drug product intended for ingestion represents a risk-of-harm situation that meets High severity criteria.

Plain-English summary

Efficient Laboratories, Inc. is recalling Rompe Pecho CF Cold & Flu Advanced Formula, a 6 fluid ounce oral cough and cold medicine containing dextromethorphan HBr, guaifenesin, and phenylephrine HCl. The recall was initiated due to microbial contamination of the non-sterile product.

The affected product is NDC 58593-235-06 in lot numbers 19F88 (expiration June 2022) and 19G164 (expiration July 2022). A total of 10,833 bottles were distributed nationwide within the United States.

Consumers who have purchased this product should stop using it immediately. Those with questions or concerns are advised to contact Efficient Laboratories, Inc. or consult their healthcare provider. The FDA is overseeing this Class II recall.

The recalled product

Product
ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL)
Brand
ROMPE PECHO
Manufacturer
Efficient Laboratories, Inc.
Category
Drug — Over-the-Counter Cough and Cold Medicine
Hazard
Affected units
10,833

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 (2)

  • Lot #: 19F88 Exp. June 2022
  • 19G164 Exp. July 2022.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same brand · ROMPE PECHO

Same manufacturer · Efficient Laboratories, Inc.

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Same hazard · microbial contamination

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