RecallRadar

FDA Drug recall D-0092-2018

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

On 2017-11-29 the FDA classified a Class II recall of Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202,… by Lupin, citing 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….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0092-2018
ClassificationClass II
Statusterminated
Initiated2017-11-17
Published2017-11-29
Last updated2026-09-13 11:51 UTC
CompanyLupin
DistributionUS

Product

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

Reason

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.

Identifiers

ndc68180-485-03
ndc68180-485-09
ndc68180-485-02
ndc68180-486-09
ndc68180-486-02
ndc68180-486-03
ndc68180-487-09
ndc68180-487-02
ndc68180-487-03
ndc68180-488-09
ndc68180-488-02
ndc68180-488-03
code_infoLot # G702459, Exp 2/20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0092-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.