- Firm Announcement Date:
- February 15, 2018
- FDA Publish Date:
- June 06, 2019
- Product Sort:
- Purpose for Announcement:
- Firm Title:
- Apace Packaging LLC
- Model Title:
- Product Description:
Acyclovir Pill, USP, 400mg, 50ct Unit Dose
Fountain Run, KY, Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Pill, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15 (Carton), NDC# 50268-061-11 (Blister Card), Lot Quantity 19900, to the Retail degree. These merchandise have been recalled because of a product mix-up. A small variety of blister playing cards containing Acyclovir Tablets, 400mg, UD Blister Playing cards could doubtlessly additionally embody Torsemide, 20mg, Tablets.
Lacking a dose of Acyclovir Tablets may trigger a reactivation of a virus being handled. Unintentional dosing of Torsemide, 20mg, Tablets may trigger extreme urination. Severe adversarial occasions reported within the scientific research, for which a drug relationship couldn’t be excluded, had been atrial fibrillation, chest ache, diarrhea, digitalis intoxication, gastrointestinal hemorrhage, hyperglycemia, hyperuricemia, hypokalemia, hypotension, hypovolemia, shunt thrombosis, rash, rectal bleeding, syncope, and ventricular tachycardia. To this point, Apace Packaging LLC has not acquired any stories of adversarial occasions associated to this recall. Acyclovir Pill, USP, 400mg 50ct Unit Dose (NDC# 50268-061-15/50268-061-11) is used for the acute remedy of herpes zoster (shingles), for the preliminary remedy and administration of recurrent episodes of genital herpes, and for the remedy of chickenpox. Torsemide, 20mg, Tablets are used for the remedy of edema and hypertension. The product is packaged in 50-count hospital unit dose cartons (10 unit doses per card, 5 playing cards per carton). The affected lot of Acyclovir 400mg Pill is Lot 19900 with an expiration date of 05/2019. The topic product was totally distributed to R&S Northeast, after which additional distributed nationwide.
Apace Packaging LLC has notified its distributors and clients by e mail and is arranging for return of all recalled product. Distributors which have any of the topic product which is being recalled ought to contact Buyer Service at AvKARE, Inc. at 931-292-6222 to rearrange for the return of the product.
Shoppers with questions relating to this recall can contact Apace Packaging by 270-434-2722 Monday-Friday (8am – 4pm CST). Shoppers ought to contact their doctor or healthcare supplier if they’ve skilled any issues that could be associated to taking or utilizing these drug merchandise.
Hostile reactions or high quality issues skilled with using this product could also be reported to the FDA’s MedWatch Hostile Occasion Reporting program both on-line, by common mail or by fax.
This recall is being performed with the data of the U.S. Meals and Drug Administration.
Firm Contact Info