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Class II: temporary or reversible health riskTerminated

Procaps S.A. de C.V. Bacaolinita Liquid Dietary Supplement With Recall

Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl

Procaps S.A. de C.V.

Risk level
Class II
Reported by FDA
Jun 14, 2023
Recall ID
F-0978-2023
Check your lot numberHow we source this data

Summary

Procaps S.A. de C.V. recalled Bacaolinita Liquid Dietary Supplement With starting May 19, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0978-2023 on Jun 14, 2023. Reason: PEG-40 not declared as an ingredient on the label. Status: Terminated.

Why it was recalled

PEG-40 not declared as an ingredient on the label

Product description

Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardboard box

Lot numbers, UPCs & expiration codes

Lot #: 1358739, 1379697, 1379718, 1387103, 1404273, 1416127, 1420872, 1423729, 1451962

Where it was sold

DE, TX, CA

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0978-2023
Classification
Class II
Status
Terminated
Recall initiated
May 19, 2023
FDA report date
Jun 14, 2023
Quantity
33,684 Boxes
Recall type
Voluntary: Firm initiated
Recalling firm
Procaps S.A. de C.V.

Original FDA data

Every field from FDA enforcement report F-0978-2023, exactly as published.

Show all FDA fields
City
Soyapango
Status
Terminated
Country
El Salvador
Event ID
92385
Address
Boulevard Of The National Army, Km 5 1/2
Code information
Lot #: 1358739, 1379697, 1379718, 1387103, 1404273, 1416127, 1420872, 1423729, 1451962
Report date
Jun 14, 2023
Product type
Food
Recall number
F-0978-2023
Classification
Class II
Recalling firm
Procaps S.A. de C.V.
Product quantity
33,684 Boxes
Termination date
Nov 30, 2023
Reason for recall
PEG-40 not declared as an ingredient on the label
Voluntary / mandated
Voluntary: Firm initiated
Product description
Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardboard box
Distribution pattern
DE, TX, CA
Recall initiation date
May 19, 2023
Initial firm notification
E-Mail
Center classification date
Jun 7, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0978-2023, published Jun 14, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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