Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags Nationwide
Pharmedium Services LLC is voluntarily recalling 864 bags of repinephrine bitartrate injection because the drug was subpotent. The recall covers nationwide distribution in the U.S.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Pharmedium Services LLC is voluntarily recalling 864 bags of NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP. The product is a high-alert, prescription-only medication distributed nationwide in the United States.
The recall was initiated because the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The affected lots include 193040035S, 193120031S, 193150024S, 193180030S, 193240028S, and 193250022S, with expiration dates ranging from December 2019 to January 2020.
The FDA classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare providers and pharmacies should check their inventory for these specific lot numbers and stop using the product if found.
The recalled product
- Product
- NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 864
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 (12)
- Lot #s: 193040035S
- Exp. 12/29/2019
- 193120031S
- Exp. 01/08/2020
- 193150024S
- Exp. 01/09/20
- 193180030S
- Exp. 01/12/20
- 193240028S
- Exp. 01/18/20
- 193250022S
- Exp. 01/19/20.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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