Multi-event March 2013 FDA Recall Camrese by Teva Pharmaceuticals Usa, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on March 14, 2013 for the product Camrese. The FDA reported the reason for recall as failed impurity/degradation specification; an impurity identified as n-butyl-benzene sulfonamide (nbbs) detected during impurity testing. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-496-2013
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
03-14-2013
06-05-2013
17,108 blister packs
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.
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
Batch or Lot Expiration Information
Lot# NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.
Recall Number: D-497-2013
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
03-14-2013
06-05-2013
120,049 blister packs
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.
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
Batch or Lot Expiration Information
Lot# NDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A, exp 3/2013; 33802967A, exp 8/2013; 33803529A, exp 10/2013; and 33803609A, exp 11/2013.
