Allergan Recalls NORCO Tablets Due to Missing Controlled Substance Labeling
Allergan is recalling 8 bottles of NORCO tablets because the primary label is missing the required CII controlled drug classification indication.
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 by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.
Plain-English summary
Allergan USA, Inc. is recalling 8 bottles of NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles. The specific lot number is 544821A with an expiration date of 07/19. The product is distributed nationwide in the USA.
The recall was initiated because the primary label does not have the required "CII" controlled drug classification indication. This is a labeling issue classified as "Not Elsewhere Classified" by the FDA.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
- Manufacturer
- ALLERGAN
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8
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 # 544821A
- Exp 07/19
Distribution
Distributed nationwide across the United States.
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