LNK International Recalls Equate Nighttime Sleep Aid Due to Microbial Contamination
LNK International is recalling specific lots of Equate Nighttime Sleep Aid because of microbial contamination in the non-sterile product.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
LNK International, Inc. is recalling specific lots of Equate Nighttime Sleep Aid (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL). The recall is due to microbial contamination of the non-sterile product.
The affected lots are P300456, P300475, P300482, and P300489, all with an expiration date of 09/30/2020. The total quantity involved is 13,500 liters for lots P300456, P300475, and P300489, and 3,600 liters for lot P300482. The product was distributed nationwide in the USA.
Consumers should check their products for the listed lot numbers and expiration dates. If they have the affected product, they should stop using it and contact LNK International, Inc. for further instructions.
The recalled product
- Product
- NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL)
- Brand
- NIGHTTIME SLEEP AID
- Manufacturer
- LNK International, Inc.
- Category
- Drug — OTC Sleep Aid
- Hazard
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 (5)
- Lot #: P300456
- P300475
- P300482
- P300489
- Exp 09/30/2020
UPCs (2)
- 0681131175951
- 681131175951
Distribution
Distributed nationwide across the United States.
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