D-0092-2018 Class II Terminated
FDA drug recall D-0092-2018 was initiated by Lupin Limited on November 17, 2017 and is designated Class II. 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, 4… The recall status is terminated (terminated March 15, 2019). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2017
- Initiation Date
- November 17, 2017
- Termination Date
- March 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
Product was distributed throughout the United States, including Puerto Rico.
Code Information
Lot # G702459, Exp 2/20