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Bd bbl sensi disc ampicillin 2 μg (am-2)

Official notice

20 Nov 2024

Last checked

20 Nov 2024

Medium riskHealth Canada

An official Health Canada notice concerns Bd bbl sensi disc ampicillin 2 μg (am-2). BD identified through potency test, as part of special stability test requests to monitor Ampicillin AM-2, unsatisfactory results of 65% at 18 months. The potency acceptance criteria is 80-140% and product shelf life is 24 months. A retest with control batch and extended sampling confirmed the low potency results. Recall Start Date: November 6, 2024 Published 2024-11-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76548

Official notice

2024-11-20

The hazard

BD identified through potency test, as part of special stability test requests to monitor Ampicillin AM-2, unsatisfactory results of 65% at 18 months. The potency acceptance criteria is 80-140% and product shelf life is 24 months. A retest with control batch and extended sampling confirmed the low potency results. Recall Start Date: November 6, 2024

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76548

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Affected products

Product 1

Affected products - BD BBL Sensi Disc Ampicillin 2 Μg (AM-2), Lot or serial number - 3234190 3184064 2339360 3010977, Model or catalog number - 231263

Risk / hazard

BD identified through potency test, as part of special stability test requests to monitor Ampicillin AM-2, unsatisfactory results of 65% at 18 months. The potency acceptance criteria is 80-140% and product shelf life is 24 months. A retest with control batch and extended sampling confirmed the low potency results. Recall Start Date: November 6, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Becton Dickinson And [bd], Bd Bbl Sensi Disc Ampicillin 2 Μg.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76548

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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