Reported Nov 13, 2019 · Terminated

S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · 6828 E Brown Rd Ste 101 · Mesa, AZ · 85207-3761

S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX

Lot codes and dates: 12 of 12 products
Products covered by this recall
# Product as published
1 Lot #:a) S07292019DH@01, Exp 9/29/19
2 S07232019DH@06, Exp 9/23/19
3 S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/11/19
4 S06112019DH@11, Exp 8/11/19
5 S06142019DH@02, Exp 8/14/19
6 S06162019DH@01, 8/16/19,S06182019DH@34, Exp 8/18/19
7 S06242019DH@16, Exp 8/24/19
8 S06302019DH@05, Exp 8/30/19, S07102019DT@16, Exp 9/10/19
9 S07162019DH@02, Exp
10 9/16/19, S07262019DH@03, Exp 9/26/19
11 S08022019DH@02, Exp 10/2/19
12 S07232019DH@06, Exp 9/23/19, c) S07102019DT@07, Exp 9/10/19
Amount recalled: 81 vials

The agency filed one notice per product. You are reading one of them; the other 99 are below.

87 more are in the archive.

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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