PlainRecordsFDA · Drug recall
Cefuroxime 10mg/mL INJ 0.5 mg…
- Date
- April 10, 2019
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Pacific Compounding Pharmacy & Consultations Inc
- Product
- Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
- Reason
- Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
- Distribution pattern
- California
- Quantity
- 41.4 mL
- Codes and lots
- Lot # 07232018@15 BUD 9/6/18 (frozen)
- Recall started
- Aug. 23, 2018
- Recall number
- D-1076-2019
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-1076-2019. The agency record governs; check it and the company before acting.