RecallRadar

FDA Drug recall D-0807-2016

Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102

On 2016-04-13 the FDA classified a Class II recall of Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102 by Meditech Laboratories, citing lack of Assurance of Sterility: incomplete or missing data regarding production.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0807-2016
ClassificationClass II
Statusterminated
Initiated2016-03-14
Published2016-04-13
Last updated2026-09-13 11:51 UTC
CompanyMeditech Laboratories
DistributionUS

Product

Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Reason

Lack of Assurance of Sterility: incomplete or missing data regarding production.

Identifiers

code_infoLot#: 020716-0, Exp 05/07/16

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-0807-2016%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.