Multi-event March 2013 FDA Recall Portia by Teva Pharmaceuticals Usa, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on March 12, 2013 for the product Portia. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-246-2013
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
03-12-2013
04-17-2013
71,893 dispensers
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-15-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Batch or Lot Expiration Information
Lot# : 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
Affected Packages Involved in this Recall
Recall Number: D-245-2013
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
03-12-2013
04-17-2013
17,661 blister cards
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-15-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58.
Batch or Lot Expiration Information
Lot# : 33801951A, and 33802189A, Exp 03/13
