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Class III: unlikely to cause harmTerminated

Prolacta Bioscience Prolact CR Recall

Prolact CR

Prolacta Bioscience · Duarte, CA

Risk level
Class III
Reported by FDA
Mar 6, 2019
Recall ID
F-1099-2019
Check your lot numberHow we source this data

Summary

Prolacta Bioscience recalled Prolact CR starting Jan 29, 2019. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-1099-2019 on Mar 6, 2019. Reason: Shipped lot was un released and under quarantine pending investigation closures. Status: Terminated.

Why it was recalled

Shipped lot was un released and under quarantine pending investigation closures.

Product description

Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, Net 40 mL (1.2 fl.oz. Intended for premature/LBW Infants fed human milk. Ingredients: Human milk cream and human milk ultrafiltration permeate. Manufactured by: Prolacta Bioscience, Inc., City of Industry, CA 91746

Lot numbers, UPCs & expiration codes

Lot: CC101806USA; Expiration: 11/19/20

Where it was sold

One customer in NC

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-1099-2019
Classification
Class III
Status
Terminated
Recall initiated
Jan 29, 2019
FDA report date
Mar 6, 2019
Quantity
16 bottles (1 case with 4 individual bottles per carton)
Recall type
Voluntary: Firm initiated
Recalling firm
Prolacta Bioscience

Original FDA data

Every field from FDA enforcement report F-1099-2019, exactly as published.

Show all FDA fields
City
Duarte
State
CA
Status
Terminated
Country
United States
Event ID
82034
Address
1800 Highland Ave
Code information
Lot: CC101806USA; Expiration: 11/19/20
Postal code
91010-2837
Report date
Mar 6, 2019
Product type
Food
Recall number
F-1099-2019
Classification
Class III
Recalling firm
Prolacta Bioscience
Product quantity
16 bottles (1 case with 4 individual bottles per carton)
Termination date
Mar 4, 2019
Reason for recall
Shipped lot was un released and under quarantine pending investigation closures.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, Net 40 mL (1.2 fl.oz. Intended for premature/LBW Infants fed human milk. Ingredients: Human milk cream and human milk ultrafiltration permeate. Manufactured by: Prolacta Bioscience, Inc., City of Industry, CA 91746
Distribution pattern
One customer in NC
Recall initiation date
Jan 29, 2019
Initial firm notification
E-Mail
Center classification date
Feb 27, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1099-2019, published Mar 6, 2019. View the source record (openFDA) · FDA enforcement reports

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

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