COMPANY ANNOUNCEMENT
Mid Valley Pharmaceutical LLC Issues Voluntary Recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup Due to Potential Contamination with Burkholderia Cepacia
This recall has been completed and FDA has terminated this recall.
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
Generic Drugs - Reason for Announcement:
-
Recall Reason DescriptionBurkholderia Cepacia
- Company Name:
- Mid Valley Pharmaceutical
- Brand Name:
-
Brand Name(s)Doctor Manzanilla
- Product Description:
-
Product DescriptionAllergy, cough medicine
Company Announcement
Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.
Doctor Manzanilla Cough & Cold is sold over the counter for relief of cough, nasal decongestion, throat irritation, sneezing, itching watery eyes, and bronchial irritation. Doctor Manzanilla Allergy & Decongestant Relief is sold over the counter for relief of allergy, nasal decongestion, itchy throat, sneezing, itchy watery eyes, and as an antihistamine. Product was distributed locally in the Rio Grande Valley, Texas to retailers and pharmacies. The following lots are being recalled:
| Product | Bottle Size | UPC | Lot # | Expiration |
|---|---|---|---|---|
| Doctor Manzanilla Allergy & Decongestant Relief | 4 FL OZ. (118 ml) | 7 62558 00204 1 | 23221701 | 05/19 |
| Doctor Manzanilla Cough & Cold | 4 FL OZ. (118 ml) | 7 62558 00316 1 | 23221701 | 05/19 |
Mid Valley Pharmaceutical is notifying its distributors by email and is arranging for return of all recalled products. Consumers/distributors/retailers that have Doctor Manzanilla products which are being recalled should stop using/selling/distributing and return product to the place of purchase.
Consumers with questions regarding this recall can contact Mid Valley Pharmaceutical by (956) 689-6192 on Monday to Friday 9:00AM to 5:00 PM, Central Standard Time. 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
(http://www.fda.gov/MedWatch/report.htm)
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm
(http://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.
Company Contact Information
- Consumers:
- Mid Valley Pharmaceutical, LLC
- (956) 689-6192
