RecallRadar

FDA Drug recall D-0639-2016

CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only

On 2016-02-03 the FDA classified a Class II recall of CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only by Sentara Enterprises, citing lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0639-2016
ClassificationClass II
Statusterminated
Initiated2015-09-18
Published2016-02-03
Last updated2026-09-13 11:51 UTC
CompanySentara Enterprises
DistributionNC, VA

Product

CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Reason

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Identifiers

code_infoAll Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15

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-0639-2016%22

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