RecallRadar

FDA Drug recall D-0223-2018

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufact…

On 2018-01-24 the FDA classified a Class III recall of Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufact… by Hetero Labs Unit Iii, citing presence of foreign substance: metallic razor blade was found in one bottle.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0223-2018
ClassificationClass III
Statusterminated
Initiated2017-12-22
Published2018-01-24
Last updated2026-09-13 11:52 UTC
CompanyHetero Labs Unit Iii
DistributionUS

Product

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10

Reason

Presence of foreign substance: metallic razor blade was found in one bottle.

Identifiers

ndc31722-510-30
ndc31722-510-01
ndc31722-510-10
ndc31722-510-90
ndc31722-511-30
ndc31722-511-01
ndc31722-511-10
ndc31722-511-90
ndc31722-512-30
ndc31722-512-01
ndc31722-512-10
ndc31722-512-90
ndc31722-513-30
ndc31722-513-01
ndc31722-513-10
ndc31722-513-90
ndc31722-514-30
ndc31722-514-01
ndc31722-514-05
ndc31722-514-90
code_infoLot #: E171280, Exp 06/19

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0223-2018%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.