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.
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 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
- 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 (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.
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