Drug 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.
D-245-2013
Product summary
- Event
- Event 64607
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,661 blister cards
- Official record key
drug-enforcement:D-245-2013
Official wording
Reason: Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Code information: Lot #: 33801951A, and 33802189A, Exp 03/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification