Children's NyQuil recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Children's NyQuil Cold & Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: the record cites insanitary conditions with rodent activity affecting distributed product, and no illnesses are reported.
Plain-English summary
Children's NyQuil Cold & Flu, Berry, 8oz, 12 count distributed by Gold Star Distribution Inc is being recalled.
The reason given in the enforcement record is CGMP deviations: insanitary conditions including rodent exposure and activity in the firm's distribution center.
The recall covers all lots within expiry distributed by Gold Star Distribution. The record does not state a quantity. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Consumers who have this product should not use it and should follow the retailer's return instructions.
The recalled product
- Product
- Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU…
- Manufacturer
- Medline Industries, LP
- Category
- Drug — Cold and flu
- Affected units
- 1,725
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 (14)
- Medline kit SKU DYKS1339B
- UDI/DI 10195327386726(EA) 40195327386727 (CS)
- Lot Number 25HMC849
- Medline kit SKU DYKS1339C
- UDI/DI 10198459523434(EA) 40198459523435 (CS)
- Lot Number 25IMG807
- Lot Number 25JMF937
- Medline kit SKU DYKS1359B
- UDI/DI 10195327566449(EA) 40195327566440 (CS)
- Lot Number 25JMD518
- Medline kit SKU DYKS1534D
- UDI/DI 10198459310911(EA) 40198459310912 (CS)
- Lot Number 25HMD322
- Lot Number 25JMG543.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Medline Industries, LP under a single FDA (Devices) 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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