Skin Test Antigen, Tuberculosis Skin Test
Where is Tuberculin Purified Protein Derivative made?
3 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 1 factory in Canada.
Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi Vaccines US Inc. Tubersol5 [iU] per 0.1 mL · NDC 49281-752 | Sanofi Vaccines Canada Ltd.Makes it | North York, Canada | Not inspected on record |
| Boiron1 [hp_M]/[hp_M], 8 [hp_X], 10 [hp_M]/10[hp_M], 12 [hp_C]/12[hp_C], 15 [hp_C]/15[hp_C], 30 [hp_C]/30[hp_C] · NDC 0220-7948, 0220-7949, 0220-7944 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc. Aplisol5 [iU] per 0.1 mL · NDC 42023-104 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Tuberculin Purified Protein Derivative in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-1336,50090-0261,50090-1668 - Physicians Total Care, Inc.:
54868-2972 - TYA Pharmaceuticals:
64725-0104
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.