The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0292-2022·Announced 2021-12-29

OTC Expectorant Recall: Microbial Contamination in Rompe Pecho

Efficient Laboratories is recalling Rompe Pecho guaifenesin expectorant in 4 fl oz and 6 fl oz bottles due to microbial contamination of non-sterile products. The affected product was distributed nationwide.

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: This is an FDA Class II recall involving microbial contamination of a non-sterile OTC drug product distributed nationwide. Class II recalls with contamination hazards meet the threshold for Severe severity even in the absence of reported illnesses.

Plain-English summary

Efficient Laboratories, Inc. is recalling Rompe Pecho Ex Expectorant due to microbial contamination of non-sterile products. The recalled product includes 4 fl oz (118 mL) bottles (NDC 58593-829-04) and 6 fl oz (178 mL) bottles (NDC 58593-829-06).

The product was distributed nationwide within the United States. Affected lot numbers include: for the 4 fl oz size, lots 19H20 (expiration August 2022), 19A418 (expiration January 2022), and 19E411 (expiration May 2022); for the 6 fl oz size, lots 19H20 (expiration August 2022), 19J98 (expiration September 2022), 19A418 (expiration January 2022), and 19E411 (expiration May 2022). Approximately 7,800 bottles of the 4 fl oz size and 16,417 bottles of the 6 fl oz size were distributed.

Consumers who have purchased this product should stop using it. Those with questions about the recall may contact Efficient Laboratories, Inc. at the address listed on the product packaging.

The recalled product

Product
ROMPE PECHO (GUAIFENESIN)
Brand
ROMPE PECHO
Manufacturer
Efficient Laboratories, Inc.
Category
Drug — OTC 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 (5)

  • Lot #: a) 19H20 Exp. August 2022
  • 19A418 Exp. January 2022
  • 19E411 Exp. May 2022
  • b) 19H20 Exp. August 2022
  • 19J98 Exp. September 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 →

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