What is Phenobarbital?
Phenobarbital is a barbiturate which aids in relaxing and helping someone go to sleep. It can be used for the short-term treatment of sleeplessness, the relief of anxiety, tension, and fear, and the treatment of certain types of seizures, especially in emergency situations. It may also be used for other conditions as determined by your doctor.
You can read more about phenobarbital here.
C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer / user level. The manufacturer received a confirmed customer complaint that there has been a labeling error – a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.
This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.
C.O. Truxton’s Phenobarbital Tablets, USP, 15 mg, is indicated for use as a sedative or anticonvulsant and is packaged in 1000 count bottles, NDC 0463-6160-10, UPC 7 04636160106, lot number 70952A, expiration date 11/17. The 15 mg table is debossed with “West-ward 445” on one side and blank on the reverse side. The product was distributed Nationwide in the USA to Physician & Veterinarian Treatment Centers.
What do you have to do next?
C.O. Truxton, Inc. is notifying all customers on record who purchased the affected product via US Mail which includes a recall letter, recall response form and is arranging for full credit returns, replacements, etc. of all recalled product. Consumers / distributors / retailers that have recalled product should stop using the product and return their product to their place of purchase.
If you have any questions regarding this recall can contact C.O. Truxton, Inc. by phone at +1-856-933-2333, Monday to Friday, between the hours of 9am and 5pm (EST). Consumers should contact their physicians or healthcare providers if they have experienced any problems that may be related to taking or using this drug product.
The FDA is encouraging all health care professionals and patients to report any adverse events or side effects related to the use of phenobarbital to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or call 1-800-332-1088 (US Toll-free number).
Read the full FDA alert here.