CLASS II Drug recall · Reported 25 Jun 2014 · FDA Enforcement Report
Tev-tropin [somatropin (rDNA origin) for injection] 5 mg (15 IU) recalled
Ferring Pharmaceuticals is recalling Tev-tropin [somatropin (rDNA origin) for injection] 5 mg (15 IU), distributed in Pennsylvania. The recall was initiated on 28 Apr 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1385-2014
- FDA event ID
- 68407
- Recalling firm
- Ferring Pharmaceuticals, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Apr 2014
- FDA classified
- 17 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Apr 2014 | Recall initiated by company | |
| 17 Jun 2014 | Classified by FDA | +50 days |
| 25 Jun 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46
Where it was distributed
PA
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # H11599A; Exp. 03/16 Lot # H11599B; Exp. 03/16 Lot # H12913A; Exp. 05/16 Lot # H12913B; Exp. 05/16 Lot # H12914A; Exp. 05/16 Lot # H12914B; Exp. 05/16 Lot # H13846A; Exp. 07/16 Lot # H13846B; Exp. 07/16
Where was it sold?
PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Tev-tropin [somatropin (rdna Origin) ] recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tev-tropin (somatropin (rDNA origin) for injection) 5 mg (15 IU) recalled | Ferring Pharmaceuticals | Packaging Defects | Nationwide |