Lupin Recalls Hydrocodone and Acetaminophen Tablets for Missing Labels
Lupin Pharmaceuticals is recalling 1,672 bottles of Hydrocodone Bitartrate and Acetaminophen tablets in Ohio due to missing labels.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging/labeling defect (missing label) rather than a contamination or dosage error.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 1,672 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg. The affected product is a 1000-count prescription bottle manufactured by Novel Laboratories, Inc. for Lupin Pharmaceuticals, Inc.
The recall was initiated because the product is missing its label. The specific lot number is S800257, with an expiration date of 01/20. The NDC for the recalled product is 43386-356-10.
The affected units were distributed in Ohio. Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if the label is missing. They should contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN)
- Brand
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Manufacturer
- LUPIN SOMERSET
- Category
- Drug — Prescription Medication
- 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 (2)
- Lot # S800257
- Exp. 01/20
UPCs (4)
- 0343386357031
- 0343386358014
- 0343386356010
- 343386356102
Distribution
Distributed in 1 state:
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