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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62827

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

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

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
Recalling firm
Actavis Mid Atlantic LLC
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

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
Recalling firm
Actavis Mid Atlantic LLC
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