Pecgen DMX FDA Alerts
The FDA Alerts below may be specifically about Pecgen DMX or relate to a group or class of drugs which include Pecgen DMX.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Pecgen DMX
Novis PR LLC Issues Voluntary Nationwide Recall of Pecgen DMX Due to a Labeling Error
Novis PR LLC is voluntarily recalling 5 lots of PECGEN DMX, 16 oz, a liquid cough syrup to the consumer level. The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label (example below) incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician.
| Children 6 to under 2 years of age | 1 teaspoonful (tsp) every 4 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor |
The label should state children 6 to under 12 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Risk Statement: There is no evidence that cough and cold medicines are safe or effective for young children. However, there is evidence that children have been harmed by overdoses of these products. Problems include seizures, coma, and death. Dextromethorphan can also interact with Tylenol or other cough/cold medications to be highly toxic—more than if given alone. To date, NOVIS PR LLC has not received any reports of adverse events related to this recall.
The product is used as a Cough suppressant and expectorant and is packaged in Amber plastic 16 oz bottles in cases of 12 units with NDC 52083-630-16. The affected PECGEN DMX lots include the following lot numbers and expiration dates: D80202 Exp date 02/20, D80210 Exp 02/20, D80818 Exp 09/20, D80819 Exp 09/20, D80820 Exp 09/20.
Error was discovered by an email notification of an unidentified individual alerting of incorrect information in label.
PECGEN DMX was distributed in Puerto Rico to Wholesalers and retail pharmacies. Product is only sold in Puerto Rico.
Novis PR LLC is notifying its distributors and customers by letters and phone calls the collection of the units and is arranging the return of all recalled products.
Consumers who have PECGEN DMX which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.
Distributors/retailers that have PECGEN DMX which is being recalled should stop distributing the product and must return it to place of purchase.
Consumers with questions regarding this recall can contact Novis PR LLC at (787) 767-2072 or info@kramernovis.com from Monday thru Friday, 7:30am – 4:30pm (AST).
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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup
Including store brands:
- Sunmark
- Rite-Aid
- Topcare
- Kroger
- GoodSense
- Dollar General
- Care One
- CVS
ISSUE: Perrigo Company announced that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children's guaifenesin grape liquid (100mg/5 mL) and 3 batches of its children's guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles with dosage cup in a box under multiple store brand product names. Some packages contain an oral dosing cup with incorrect dose markings. See the press release for affected label and lot numbers.
At risk populations such as those who are poor metabolizers of dextromethorphan may experience an overdose by a factor of 3, if incorrect measuring levels are used.
Consumers should be aware that an overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma. Other effects have included nausea, vomiting, tachycardia, irregular heartbeat, seizures, respiratory depression, and death. Small children who are poor metabolizers of dextromethorphan and use the product regularly over a period of several days at the mistaken dose, may develop cumulative toxicity. Moreover, adverse reactions to guaifenesin when given in high or excessive dosage may include nausea/vomiting, diarrhea, and/or abdominal pain. Therefore, an extreme overdose in an at risk population may need medical intervention, but in most cases adverse health consequences are temporary and reversible.
BACKGROUND: These recalled products are sold by distributors nationwide and distributed through retail stores.
RECOMMENDATION: Gastric decontamination is recommended after acute ingestion of greater than 10 mg/kg, if administered soon after ingestion.
Consumers that have product with the corresponding labels and batch numbers listed in the Press Release should discard the dosing device and product and may call Perrigo, toll free, Monday through Friday from 8:00 AM to 10:00 PM EST, at 1-888-345-0479, or visit mucusreliefrecall.com. Consumers should contact their physician or healthcare provider if they have any questions, or if they or their children experience any problem that could possibly be related to this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/11/2016 - Press Release - Perrigo]
Guaifenesin (Unapproved) Timed-Release Drug Products
[Posted 05/25/2007] FDA informed consumers and healthcare professionals of its intent to take action against companies that market unapproved timed-release dosage form of guaifenesin products, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from the lungs. These dosage forms are often described as extended-release, long-acting or sustained-release products that release their active ingredients over an extended period of time, reducing the number of doses needed per day. Approximately 20 firms make unapproved timed-release products containing guaifenesin that have not undergone FDA review for safety and efficacy. Mucinex, Mucinex-D, Mucinex-DM, and Humibid are the only FDA approved timed-release guaifenesin (single ingredient or combination) products. Companies marketing unapproved products containing guaifenesin in timed-release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. This action does not affect products containing guaifenesin in immediate release form.[May 25, 2007 - News Release - FDA]
Dextromethorphan
FDA issued a Talk Paper to notify the public about the abuse of dextromethorphan (DXM), an ingredient found in many over-the-counter (OTC) cough and cold remedies. The agency is working with other health and law enforcement authorities to address this serious issue and warn the public of potential harm, after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules.[May 20, 2005 - Talk Paper - FDA]
