TOPIC: Cyclobenzaprine Hydrochloride Tablets USP, 10 mg by Unichem Pharmaceuticals (USA): Recall - Due to Mislabeling
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Rheumatology
ISSUE: Unichem Pharmaceuticals (USA) is recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg because the Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets.
Risk Statement: For patients who unknowingly take Meloxicam there is a reasonable probability of serious adverse events including cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions, particularly in those patients taking concomitant non-steroidal anti-Inflammatory drugs and/or blood thinners, those who have allergies to the Meloxicam, or those with underlying illness.
The mislabeled bottles of Cyclobenzaprine Hydrochloride Tablets USP, 10mg but containing Meloxicam 7.5mg tablets, can be identified by the lot number GMML24026A and expiry of Sept 2027 and NDC 29300-415-19 printed on the label of the 90-count bottles.
The product was distributed Nationwide to distributors, and further downstream distribution occurred to retailers and subsequently consumers.
To date, Unichem Pharmaceuticals has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND:
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Meloxicam Tablets USP, 7.5 mg is a non-steroidal anti-inflammatory drug, indicated for use in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Rheumatoid Arthritis.
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Cyclobenzaprine Hydrochloride Tablets USP, 10mg is a muscle relaxer and indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers with questions regarding this recall can Inmar at 1-877-840-5109 or via email a to rxrecalls@inmar.com.
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Downstream trading partners that have Cyclobenzaprine Hydrochloride Tablets USP, 10mg with Lot# GMML24026A, Exp Sept 2027, which is being recalled, should not further distribute, this medication, and notify their customers accordingly.
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Retail pharmacies should not dispense from this lot number, GMML24026A, and call the number provided for guidance on how to return this drug product.
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Any pharmacy who has dispensed this lot of Cyclobenzaprine, should notify the consumer. Consumers should return the medication to the pharmacy they received their prescription from.
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