Recalls / Class III
Class IIID-245-2013
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.
- Brand name
- Portia
- Generic name
- Levonorgestrel And Ethinyl Estradiol
- NDC
- 0555-9020
- FDA application
- ANDA075866
- Affected lot / code info
- Lot #: 33801951A, and 33802189A, Exp 03/13
Why it was recalled
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 17,661 blister cards
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-12
- FDA classified
- 2013-04-10
- Posted by FDA
- 2013-04-17
- Terminated
- 2014-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-245-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.