Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Welchol Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
Affected NDC
65597-0701-18
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Daiichi Sankyo Pharma Development
- NDC code
- 65597-701-18
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1505-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Daiichi Sankyo Pharma Development
All 2014 recalls
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Benicar Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Tribenzor Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Other temperature excursion recalls from 2014
All temperature excursion recalls
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I · High risk
Propofol Injectable Emulsion
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Ketorolac Tromethamine Inj.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
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