Key Takeaway

Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13 by Calvin Scott & Company, Inc. was recalled on July 27, 2020. The hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

FDA Drug Class II Terminated

Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13

Recalled: July 27, 2020 ~N/A units affected D-1520-2020

Description

Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13

Hazard / Reason

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13

Drugs

Company Information

Calvin Scott & Company, Inc.

Albuquerque, NM, United States

View all 24 recalls by Calvin Scott & Company, Inc. →

Distribution

Nationwide within the United States

Related Recalls

FDA Drug Class III

Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50

January 15, 2021
FDA Drug Class I

Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05

January 15, 2021
FDA Drug Class II

Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01

September 16, 2020
FDA Drug Class II

Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10

September 16, 2020
FDA Drug Class II

Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01

September 16, 2020
FDA Drug Class II

Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin S

July 27, 2020

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.