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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

Alvogen, Inc: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Agency Publication Date: April 4, 2017
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Affected Products

Product: Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.

Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, Exp. 10/2018

Lot Numbers:
BXH1P22
Product: Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05

Lot #: BXH1P21A, Exp. 11/2017

Lot Numbers:
BXH1P21A
Product: Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05

Lot #: BXH1BE1A, BXH1P41A, Exp. 01/2018.

Lot Numbers:
BXH1BE1A
Product: Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.

Lot Numbers:
BXH1P41
Product: Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.

Lot #: BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1, Exp. 03/2018; BXH1P52, Exp. 05/2018; BXHBKF1A, and BXHB8S1A, Exp. 10/2018.

Lot Numbers:
BXH1P51
Product: Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305

Lot #: BXH66D1A, Exp. 03/2018

Lot Numbers:
BXH66D1A
Product: Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401

Lot #: BXHBJD1A, Exp. 10/2018

Lot Numbers:
BXHBJD1A
Product: Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501

Lot #: BXCUE1A, Exp. 01/2019

Lot Numbers:
BXCUE1A
Product: Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601

Lot #: BXHD7U1A, Exp. 10/2018

Lot Numbers:
BXHD7U1A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76664
Status: Resolved
Manufacturer: Alvogen, Inc
Manufactured In: United States

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.