CLASS III Drug recall · Reported 10 Apr 2013 · 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 nationwide in the US. The recall was initiated on 1 Feb 2013 and the FDA has classified it as Class III.
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-240-2013
- FDA event ID
- 64339
- Recalling firm
- Ferring Pharmaceuticals, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Feb 2013
- FDA classified
- 2 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Feb 2013 | Recall initiated by company | |
| 2 Apr 2013 | Classified by FDA | +60 days |
| 10 Apr 2013 | 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
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
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). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Which lots are affected?
LOT #201131320087 Exp 09/15
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 II | Tev-tropin [somatropin (rDNA origin) for injection] 5 mg (15 IU) recalled | Ferring Pharmaceuticals | Packaging Defects | PA |