Reported Jun 6, 2018 · Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel…
Lupin Somerset
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LUPIN SOMERSET · 400 Campus Dr · Somerset, NJ · 08873-1145
Is this the product you have?
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only
- Manufactured byNovel Laboratories, Inc
- Somerset NJ 08873 Manufactured forLupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
- Lot codes and dates
Lot # S800257Exp. 01/20
- Amount recalled
- 1,672 (1000-count) bottles
Where it was sold
Why it was recalled
Labeling: Missing Label
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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