Class II · Moderate risk
Spiriva Handihaler
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
SPIRIVA HandiHaler (Tiotropium Bromide)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
Affected NDCs
0597-0075-27
0597-0075-41
0597-0075-47
0597-0075-75
Compare with the code on your package — it is the most precise check available.
Drug: Tiotropium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Spiriva HandiHaler Tiotropium Bromide NDC 00597-0075 |
MONOHYDRATE 18 ug/1 | Capsule Oral|respiratory (inhalation) |
Boehringer Ingelheim Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- NDC code
- 0597-0075-27
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1057-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tiotropium recalls
See all
Class II · Moderate risk
Spiriva HandiHaler
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
Class III · Low risk
Spiriva HandiHaler
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Other recalls by Boehringer Ingelheim Roxane Inc
All 2013 recalls
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class II · Moderate risk
Combivent Respimat
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class II · Moderate risk
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
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