FDA Drug recall D-66207-001
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUS…
- FDA Drug
- Class III
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class III recall of GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUS… by Hi Tech Pharmacal, citing subpotent; phenylephrine HCl.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66207-001 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-09-04 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hi Tech Pharmacal |
| Distribution | PR |
Product
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716
Reason
Subpotent; phenylephrine HCl
Identifiers
| code_info | 1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66207-001%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.