CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Amantadine HCl Capsules, USP, 100 mg recalled by Apace KY
Apace KY is recalling Amantadine HCl Capsules, USP, 100 mg, distributed in Kentucky. The recall was initiated on 19 Jun 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1035-2017
- FDA event ID
- 77601
- Recalling firm
- Apace KY, Fountain Run, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jun 2017
- FDA classified
- 31 Jul 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 19 Jun 2017 | Recall initiated by company | |
| 31 Jul 2017 | Classified by FDA | +42 days |
| 9 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Product as listed by the FDA
Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Where it was distributed
KY
Questions about this recall
Why was it recalled?
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Which lots are affected?
Lot: 16710, exp 07/2018
Where was it sold?
KY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77601| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cyclobenzaprine HCl Tablets, USP, 5 mg Unit Dose recalled by Apace KY | Apace KY | Other | KY |
More recalls from Apace KY
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acyclovir Tablets, USP, 400 mg dose blisters [ recalled by Apace KYAcyclovir | Apace KY | Other | Nationwide |
| Drug | CLASS II | Cyclobenzaprine HCl Tablets, USP, 5 mg Unit Dose recalled by Apace KY | Apace KY | Other | KY |
| Drug | CLASS III | Minocycline Hydrochloride Capsules USP, 100 mg* Dose blisters recalled | Apace KY | Labeling Errors | Nationwide |
| Drug | CLASS III | Enalapril Maleate Tablet, USP 5mg, Rx, Apace Packaging LLC recalled | Apace KY | Packaging Defects | Nationwide |
Other Amantadine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Amantadine Hydrochloride Oral Solution USP, 50mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Amantadine Hydrochloride Tablets 100 mg recalled by Cardinal HealthAmantadine Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Amantadine Hydrochloride Tablets, 100 mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Amantadine HCl Capsules, USP, 100 mg Unite Dose recalled by AVKAREAmantadine Hcl | Avkare | Potency & Assay | Nationwide |