CLASS III Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report

Norepinephrine bitartrate 16 mg in NaCl recalled

BayCare Integrated Service Center, LLC / is recalling Norepinephrine bitartrate 16 mg in NaCl 0.9%, distributed in Florida. The recall was initiated on 14 Feb 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: Nore1620220111, Nore1620220113, Nore1620220118, Nore1620220125, Nore1620220127, Nore1620220202, Exp 3/31/22

Quantity recalled1157 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-0569-2022
FDA event ID: 89599
Recalling firm: BayCare Integrated Service Center, LLC /, Temple Terrace, FL
Classification: Class III
Status: Terminated
Recall initiated: 14 Feb 2022
FDA classified: 18 Feb 2022
Reported: 2 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Drug class: Allergy Medication

Timeline

14 Feb 2022	Recall initiated by company
18 Feb 2022	Classified by FDA	+4 days
2 Mar 2022	Published in enforcement report	+12 days

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

Reason for recall

Subpotent drug

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392

Where it was distributed

Florida

Questions about this recall

Why was it recalled?

Subpotent drug

Which lots are affected?

Lot #: Nore1620220111, Nore1620220113, Nore1620220118, Nore1620220125, Nore1620220127, Nore1620220202, Exp 3/31/22

Where was it sold?

Florida

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

More recalls from BayCare Integrated Service Center, LLC /

All 3

Reported	Class	Recall	Company	Reason	Where
21 Dec 2022Drug	CLASS I	Iohexol (300 mg Iodine/mL) Iodine/, Total Volume in syringe recalled	BayCare Integrated Service Center, LLC /	Labeling Errors	FL
11 Aug 2021Drug	CLASS II	Succinylcholine Chloride 100 mg/ (20 mg/mL) Syringes recalled	BayCare Integrated Service Center, LLC /	Sterility	FL

Other Norepinephrine Bitartrate recalls

All 21

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
28 Feb 2024Drug	CLASS II	Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg recalledNorepinephrine Bitartrate	Baxter Healthcare	Packaging Defects	Nationwide
19 Apr 2023Drug	CLASS III	Norepinephrine Bitartrate Injection, USP, 4 mg/* recalledNorepinephrine Bitartrate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide