Reported Jun 25, 2014 · Terminated
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel,…
Ferring Pharmaceuticals Inc.
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: Ferring Pharmaceuticals Inc · 4 Gatehall Dr Fl 3rd · Parsippany, NJ · 07054-4518
Is this the product you have?
- TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel
- Distributed byGate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46
- Lot codes and dates
Lot # H11599AExp. 03/16 Lot # H11599BExp. 03/16 Lot # H12913AExp. 05/16 Lot # H12913BExp. 05/16 Lot # H12914AExp. 05/16 Lot # H12914BExp. 05/16 Lot # H13846AExp. 07/16 Lot # H13846BExp. 07/16
- Amount recalled
- 129,060 cartons
Where it was sold
Why it was recalled
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
This product could cause temporary or reversible health problems — stop using it.
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