Tuesday, May 29, 2018

FDA Recalls


H-E-B Ode to Olives Sliced Salad Olives Being Recalled for Potential Glass in The Product

Committed to the quality of its products, H-E-B is voluntarily issuing an all-store precautionary recall for H-E-B Ode to Olives Sliced Salad Olives in 10-ounce glass jars with a best by date of Nov. 3, 2019 due to the possible presence of glass in the product.

There have been no injuries reported due to this incident, which customers reported to H-E-B. All products related to this recall were sold at our Texas stores and have been removed from store shelves.

H-E-B is working closely with its H-E-B Ode to Olives Sliced Salad Olivesmanufacturer to ensure all safety measures are being taken when manufacturing the product.

The voluntary recall impacts the following product with the Best By date Nov. 3, 2019:

ProductUPCPackage Size
H-E-B Ode to Olives Sliced Salad Olives412209486610 oz.
Customers who purchased the product can return it to the store for a full refund. Customers with any questions or concerns may contact H-E-B Customer Service at 1-855-432-4438 Monday through Friday from 8 a.m. to 8 p.m. Central Standard Time.  


Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules


This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. The TAYTULLA  pill pack is a 28 count blister card that has 24 “active” pink softgel capsules (with hormones) with “WC” printed on the outer shell in white to be taken for 24 days, followed by 4 maroon softgel capsules (without hormones) also imprinted with “WC” on one side to be taken for the next four days. If you are a patient in the U.S. who has used a TAYTULLA sample pack from lot 5620706, Exp. May 2019 since August 27, 2017, and are concerned that you may be impacted by this issue, please consult with your physician. This product was distributed Nationwide to healthcare providers.
Please refer to the affected lot number as well as the pictures below of the affected product.
LotProductNDCSizeExp. Date
5620706Taytulla Softgel
Capsules
1 mg/20 mcg 6X28
Sample
Outer Carton 0023-5862 31
Blister Card 0023-5862-28
Blister Box 0023-5862-29EN1216XX2
6X28 SampleMay 2019
Allegan is notifying customers by recall letter and is arranging for return of all recalled sample pack product with the lot #5620706 Exp. May 2019. Consumers who have the sample pack product with the associated lot number should notify their physician to arrange a return.  
Consumers with questions regarding this recall can contact Allergan by phone at 800-678-1605 8am-8pm EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have questions.
Adverse events 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.  
This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA)
For more information about TAYTULLA and the full prescribing information, please visit www.taytulla.com.