Multi-event August 2021 FDA Recall Rompe Pecho by Efficient Laboratories, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Efficient Laboratories, Inc. on August 24, 2021 for the product Rompe Pecho. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0292-2022 TERMINATED D-0293-2022 TERMINATED D-0290-2022 TERMINATED D-0291-2022 TERMINATED

Recall Number: D-0292-2022

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
08-24-2021
Reported
12-29-2021
Quantity
a) 7,800 bottles; b) 16,417 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89205
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Efficient Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-08-2022
Product Description About Product Description
Full technical description of the product.
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

58593-829-06 Rompe Pecho Ex
58593-829-04 Rompe Pecho Ex

Recall Number: D-0293-2022

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
08-24-2021
Reported
12-29-2021
Quantity
4,026 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89205
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Efficient Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-08-2022
Product Description About Product Description
Full technical description of the product.
Rompe 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

Batch or Lot Expiration Information

Lot# : 19G219 Exp. July 2022

Affected Packages Involved in this Recall

58593-828-08 Rompe Pecho Max Multi Symptoms

Recall Number: D-0290-2022

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
08-24-2021
Reported
12-29-2021
Quantity
10,833 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89205
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Efficient Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-08-2022
Product Description About Product Description
Full technical description of the product.
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

58593-235-06 Rompe Pecho Cf
58593-235-04 Rompe Pecho Cf
58593-235-08 Rompe Pecho Cf
58593-235-29 Rompe Pecho Cf
58593-235-10 Rompe Pecho Cf

Recall Number: D-0291-2022

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
08-24-2021
Reported
12-29-2021
Quantity
27,206 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89205
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Efficient Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-08-2022
Product Description About Product Description
Full technical description of the product.
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06

Batch or Lot Expiration Information

Lot# : 19F168 Exp. June 2022; 19G145, 19G361,19G449 19G491 Exp. July 2022.

Affected Packages Involved in this Recall

58593-275-06 Rompe Pecho Dm
58593-275-10 Rompe Pecho Dm
58593-275-04 Rompe Pecho Dm
58593-275-08 Rompe Pecho Dm