CLASS II Drug recall · Reported 11 Oct 2023 · FDA Enforcement Report

fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF recalled

Central Admixture Pharmacy Services is recalling fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume =, distributed nationwide in the US. The recall was initiated on 21 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 17-275929, Exp. 10/12/2023,
Quantity recalled60 250 mL bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0016-2024
FDA event ID
93103
Recalling firm
Central Admixture Pharmacy Services, San Diego, CA
Classification
Class II
Status
Terminated
Recall initiated
21 Sep 2023
FDA classified
4 Oct 2023
Reported
11 Oct 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility
Drug class
Pain Medication

Timeline

21 Sep 2023Recall initiated by company
4 Oct 2023Classified by FDA+13 days
11 Oct 2023Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of assurance of sterility:

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of assurance of sterility:

Which lots are affected?

Lot: 17-275929, Exp. 10/12/2023,

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

31 other products · FDA event 93103

This product is part of a recall event; the main page for the event is fentaNYL, 100 mcg/, (50 mcg/mL) Syringe recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIfentaNYL, 100 mcg/, (50 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL, 5,000 mcg/, (50 mcg/mL) recalled by Central Admixture PharmacyCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIHYDROmorphone in 0.9% sodium chloride, 6 mg/, (0.2 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL, 1,250 mcg/, (50 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL 2 mcg/mL and bupivacaine 0.125% PF recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in 0.9% sodium chloride, 10 mcg/, (10 mcg/mL) syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIPHENYLephrine in 0.9 sodium chloride, 800 mcg/, (80 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIPHENYLephrine in 0.9 sodium chloride, 400 mcg/, (40 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in 0.9% sodium chloride, 100 mcg/, (10 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in 0.9% sodium chloride, 10 mcg/, (10 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL, 250 mcg/, (50 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIketamine in 0.9% sodium chloride, 50 mg/ (10mg/mL) syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIsuccinylcholine, 200 mg/, (20 mg/mL) syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIHYDROmorphone in 0.9% sodium chloride, 15 mg/, (0.5 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IImidazolam in dextrose 5%, 50 mg/, (1 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in dextrose 5%, 300 mcg/, (10 mcg/mL) syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL, 2500 mcg/, (50 mcg/mL) recalled by Central Admixture PharmacyCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIHYDROmorphone in 0.9% sodium chloride, 10 mg/, (0.2 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in 0.9% sodium chloride, 500 mcg/, (10 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in 0.9% sodium chloride, 5,000 mcg/, (20 mcg/mL) recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in 0.9% sodium chloride, 2,500 mcg/, (10 mcg/mL) recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIPHENYLephrine in 0.9% sodium chloride, 1,000 mcg recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIHYDROmorphone in dextrose 5%, 0.5 mg/, (0.1 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL, 2500 mcg/, (50 mcg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIlidocaine 2%, 100 mg/, (20 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIHYDROmorphone in 0.9% Sodium Chloride, 30 mg/, (1 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIePHEDrine in 0.9% sodium chloride, 50 mg/, (10 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIrocuronium, 50 mg/, (10 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIfentaNYL in 0.9% sodium chloride, 1,000 mcg/, (10 mcg/mL) recalledCentral Admixture Pharmacy ServicesSterilityNationwide
CLASS IIHYDROmorphone in dextrose 5%, 3 mg/, (0.1 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide

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