PlainRecalls
FDA Drug Moderate Class II Terminated

Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09

Reported: November 29, 2017 Initiated: November 17, 2017 #D-0092-2018

Product Description

Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09

Reason for Recall

Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.

Details

Recalling Firm
Lupin Limited
Units Affected
N/A
Distribution
Product was distributed throughout the United States, including Puerto Rico.
Location
Vasco Da Gama, N/A

Frequently Asked Questions

What product was recalled?
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09. Recalled by Lupin Limited. Units affected: N/A.
Why was this product recalled?
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 29, 2017. Severity: Moderate. Recall number: D-0092-2018.