RecallRadar

FDA Drug recall D-0791-2016

Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706,…

On 2016-04-06 the FDA classified a Class II recall of Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706,… by Walter S Pharmacy, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0791-2016
ClassificationClass II
Statusterminated
Initiated2016-02-12
Published2016-04-06
Last updated2026-09-13 11:51 UTC
CompanyWalter S Pharmacy
DistributionPA

Product

Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot #: 020316 and 011216

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-0791-2016%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.