Norepinephrine Bitartrate IV Bags Recalled for Subpotency
BayCare Central Pharmacy is recalling 1,157 bags of norepinephrine bitartrate 16 mg in 250 mL saline solution distributed in Florida because the drug is subpotent—meaning it contains less active ingredient than labeled.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a manufacturing deficiency (subpotency) with no evidence of actual harm. Class III recalls are typically scored as 1 or 2, and since no adverse effects are documented, a score of 1 is appropriate.
Plain-English summary
BayCare Integrated Service Center, LLC, operating as BayCare Central Pharmacy in Temple Terrace, Florida, is recalling norepinephrine bitartrate 16 mg in 250 mL sodium chloride 0.9% solution packaged in intravenous (IV) bags. A total of 1,157 bags are affected.
The recall was initiated because the drug has been found to be subpotent, meaning the actual amount of active ingredient in each bag is less than the labeled 16 mg dose. The affected lots are: Nore1620220111, Nore1620220113, Nore1620220118, Nore1620220125, Nore1620220127, and Nore1620220202, all with an expiration date of March 31, 2022.
The recalled product was distributed to healthcare facilities in Florida. The manufacturer notified affected parties beginning February 14, 2022, through email, fax, letter, press release, telephone contact, and direct visits. This is a voluntary recall initiated by the firm. The FDA classified this as a Class III recall, and the recall was terminated on December 8, 2022.
The recalled product
- Product
- 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
- Hazard
- Affected units
- 1,157
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: Nore1620220111
- Nore1620220113
- Nore1620220118
- Nore1620220125
- Nore1620220127
- Nore1620220202
- Exp 3/31/22
Distribution
Distributed in 1 state:
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