Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
National Drug Code
Is NDC 50268-0069-15 recalled?
Amantadine HCl · 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-069-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-069-11)
Yes — this exact package was recalled
3 FDA recalls name the code 50268-0069-15 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.
1 of these recalls is still ongoing.
- Active ingredient
- Amantadine Hydrochloride
- Strength
- AMANTADINE HYDROCHLORIDE 100 mg/1
- Form
- Capsule, Liquid Filled · Oral
- Labeler
- AvPAK
- Type
- Human Prescription Drug
- Product code
- 50268-0069
Recalls naming this package
Class II · Moderate risk
Amantadine HCl Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Amantadine HCl Capsules
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
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
- 50268-0068 carboxymethylcellulose sodium 4
- 50268-0517 See recall 2
- 50268-0678 Polyvinyl Alcohol 2
- 50268-0043 Artificial Tears 1
- 50268-0061 Acyclovir 1
- 50268-0066 See recall 1
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