Class II · Moderate risk
Dicyclomine Hydrochloride Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
National Drug Code
Is NDC 0591-0795-01 recalled?
Dicyclomine Hydrochloride · 100 TABLET in 1 BOTTLE, PLASTIC (0591-0795-01)
Yes — this exact package was recalled
2 FDA recalls name the code 0591-0795-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Dicyclomine Hydrochloride
- Strength
- DICYCLOMINE HYDROCHLORIDE 20 mg/1
- Form
- Tablet
- Labeler
- Actavis Pharma, Inc.
- Type
- Drug for Further Processing
- Product code
- 0591-0795
Recalls naming this package
Class II · Moderate risk
Dicyclomine HCL
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.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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