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.
FDA recall notice · announced February 21, 2018 · Allergan
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Reason for recall
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot # 544821A, Exp 07/19
Quantity: 8 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0413-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.