Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason shortfill; reports of empty capsules.
DICYCLOMINE HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: DICYCLOMINE HCL, Tablet, 20 mg may have potentially been mislabeled as the following drug: RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD76639_1, EXP: 5/31/2014.
What was recalled
DICYCLOMINE HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591079501.
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-967-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dicyclomine recalls
See all
Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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