Alcohol prep pads recalled from one lot as a subpotent drug
Medline is recalling 222,800 alcohol prep pads from one lot because the product is subpotent.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a subpotent antiseptic may not disinfect skin as labeled, creating an infection risk, with no injuries reported.
Plain-English summary
Medline Alcohol Prep Pads, 2-ply pads with 70% isopropyl alcohol, 100 per box and 10 boxes per case, single use only, carrying NDC 55329-811-30, are being recalled as a subpotent drug.
The recall covers 222,800 eaches from lot 61224040057, distributed nationwide in the United States. The FDA has classified the recall as Class II.
Subpotency means the pads contain less alcohol than the label states, so they may not disinfect skin as intended before a procedure. The enforcement record reports no injuries.
Facilities holding the affected lot should quarantine it and follow Medline's instructions.
The recalled product
- Product
- Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
- Manufacturer
- Medline Industries, LP
- Category
- Drug — Antiseptic
- Affected units
- 222,800
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 (1)
- Lot #: 61224040057
Distribution
Distributed nationwide across the United States.
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