Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
Reported: March 18, 2020 Initiated: March 9, 2020 #D-1055-2020
Product Description
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
Reason for Recall
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 1,712 cartons
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 1,712 cartons.
Why was this product recalled? ▼
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 18, 2020. Severity: Low. Recall number: D-1055-2020.
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