PlainRecalls
FDA Drug Moderate Class II Terminated

S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80

Reported: August 12, 2015 Initiated: June 26, 2015 #D-1290-2015

Product Description

S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80

Reason for Recall

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Details

Recalling Firm
The Apothecary Shoppe LLC
Units Affected
98 mL
Distribution
Oklahoma
Location
Tulsa, OK

Frequently Asked Questions

What product was recalled?
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80. Recalled by The Apothecary Shoppe LLC. Units affected: 98 mL.
Why was this product recalled?
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 12, 2015. Severity: Moderate. Recall number: D-1290-2015.