Home / Recalls / LUPIN SOMERSET / D-0836-2018

D-0836-2018 Class III Terminated

Recalled by LUPIN SOMERSET — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
June 6, 2018
Initiation Date
May 24, 2018
Termination Date
January 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,672 (1000-count) bottles

Product Description

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102

Reason for Recall

Labeling: Missing Label

Distribution Pattern

OH

Code Information

Lot # S800257; Exp. 01/20

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  • D-1243-2019 Class III — Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Ma (April 10, 2019)
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  • D-0346-2019 Class II — Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactu (December 21, 2018)
  • D-0092-2019 Class II — Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured fo (October 5, 2018)
  • D-1214-2018 Class III — Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Man (August 23, 2018)