FDA Drug recall D-443-2014
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECT…
- FDA Drug
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECT… by Specialty Medicine Compounding Pharmacy, citing lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under th….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-443-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-19 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Specialty Medicine Compounding Pharmacy |
| Distribution | MI |
Product
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Identifiers
| code_info | All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:t09192013@20, t073…All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:t09192013@20, t07312013@12, t07312013@13, t09172013@30, t08142013@10, t08272013@28, t09052013@32, 09162013@40, t09252013@12 |
|---|
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-443-2014%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.