Reported Mar 21, 2018 · Terminated
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by:…
Novel Laboratories, Inc.
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: Novel Laboratories, Inc. · 400 Campus Dr · Somerset, NJ · 08873-1145
Is this the product you have?
- Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5
- mg Rx Only 30 Tablets Manufactured byNovel Laboratories, Inc. Somerset
- NJ 08873 Manufactured forLupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
- Lot codes and dates
M16002A (02/2018)M16246A (04/2018)M16246B (04/2018)M16434A (07/2018)M16569A (10/2018)M17015A (01/2019)S700271 (04/2019)
- Amount recalled
- 134,364 bottles (4,030,920 tablets)
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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