Dynarex obstetrical towelettes recalled over manufacturing practice deviations
Acme United Corporation is recalling Dynarex Obstetrical Towelettes Cleanser over current good manufacturing practice deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary recalls: this is a firm-initiated recall over manufacturing practice deviations with no hazard, illness or injury described in the source.
Plain-English summary
Acme United Corporation is recalling Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 5" x 7", in 100-packet cartons, made for Dynarex Corporation of Orangeburg, New York, NDC 67777-244-02. The product was distributed nationwide within the United States. The FDA has classified this recall as Class II, and the firm initiated it voluntarily.
The recall was initiated for CGMP deviations. The source record does not describe a specific hazard, illness or injury.
Affected product covers lots 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518 and 53519, with an expiry date of March 2027.
Users can identify affected product by the NDC and lot numbers above, and may contact Acme United Corporation for further information.
The recalled product
- Product
- BZK PADS (BENZALKONIUM CHLORIDE)
- Brand
- BZK PADS
- Manufacturer
- ACME UNITED CORPORATION
- Category
- Drug — Topical antiseptic
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 (9)
- Lot #: 52347-R
- 52348-R
- 52349-R
- 52350-R
- 52351-R
- 52352-R
- 53518
- 53519
- Exp. Date Mar 2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by ACME UNITED CORPORATION 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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