Recall events
/
Event 62827
Event summary
Timeline bucket August 14, 2012
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording Actavis Mid Atlantic LLC
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
2 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 2
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
D-005-2013
Recall number D-005-2013
Initiated August 14, 2012
Classification Class III
Status Terminated
Quantity 14,868 Bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Code information X111001, X111008, X111030, Exp 10/13
Distribution pattern Nationwide & Puerto Rico
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5551]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16
D-006-2013
Recall number D-006-2013
Initiated August 14, 2012
Classification Class III
Status Terminated
Quantity 19,980 Bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Code information X110042, X110051, X110064, Exp 09/13
Distribution pattern Nationwide & Puerto Rico
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5516]
FDA event record
· Exact recall-number query on openFDA
